Effect of Whole Blueberry Powder Consumption on Depression in a Central Louisiana Population

Depression Clinical Trial

Official title:

Effect of Whole Blueberry Powder Consumption on Depression: A Randomized, Double-blind, Placebo Controlled, Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04398784
• Other study ID #: 46680
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: November 26, 2019

Study information

• Verified date: May 2020
• Source: Louisiana State University, Baton Rouge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study aims to measure the effects of an intervention of 22.5 grams of freeze-dried whole blueberry powder in water drunk daily. Measures are on outcomes of depression, biological markers of inflammation and oxidative stress, and microbial populations in the intestines.

Description:

A 29 week double-blind, placebo-controlled, crossover intervention assessing the effect of a blueberries on behavioral symptoms related to depression, biological markers of inflammation and oxidative stress, and gut microbiome measures. A total of 45 participants will be randomly assigned to either a blueberry-first or placebo-first group; participants will take 22.5 grams of either freeze-dried blueberry powder or matched placebo powder mixed with water daily for 12 weeks. This period is followed by a 4 week washout period at the beginning of which all participants will stop the assigned intervention. After this washout the participants will start their crossover intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 26, 2019
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Participants with a stable diagnosis of Major Depressive Disorder (>1 year prior to enrollment)

• Males and females 18-70 years of age

• Subjects with sleep disruptions

• Subjects currently prescribed to a non-antipsychotic mono-pharmacotherapies

• English speaking subjects only (all evaluations are in English)

Subjects with the following inflammatory disorders that exhibit low to moderate symptoms:

• Hypertension (mild=140/80-160/90; moderate= 160/90-180/100)

• Asthma (requiring 2 or fewer inhalations of rescue inhaler per day)

• Gastroesophageal reflux disease

• Irritable bowel syndrome (controlled, <3 bowel movements a day)

• Arthritis (controlled)

• Chronic stomach ulcers (controlled)

• Obesity BMI <40

• Chronic pain

• Fibromyalgia

• Chronic Fatigue Syndrome

• Type I or Type II diabetes (controlled)

• Subjects that are compliant with current treatment regimens and clinic appointments

• Subjects taking intermittent or infrequent doses of acetaminophen or NSAIDs

• Subjects who currently smoke or have a history of smoking

Exclusion Criteria:

Subjects with current diagnosis or history of the following conditions; or subjects currently on medication for any of the following conditions:

• Severe Cardiovascular disease; Heart attack/pacemaker

• Cancer

• Autoimmunity Disorders

• Crohn's Disease or Ulcerative Colitis

• Alzheimer's Disease

• Parkinson's Disease

• Multiple Sclerosis

• Uncontrolled Diabetes: Type I or II

• Severe irritable bowel disease (>3 stools per day)

• Hypertension (severe >180/100)

• Hypotension (<100/60)

• Epilepsy

• Autism Spectrum Disorder

• Schizophrenia

• Psychosis/Psychotic Symptoms

• Uncontrolled Hypo/Hyperthyroidism

• Women who are pregnant, nursing, lactating, or planning to become pregnant within timeline of study

• Subjects who are blind or deaf

• Subjects who are allergic to blueberries or other similar foods or drinks (e.g. wine), or subjects who are allergic to red or blue food dye agents

• Subjects who do not like the taste of blueberries

• Subjects who do not want to disclose information related to their Major Depressive Disorder

• Subjects who do not want to be subjected to blood draws

• Subjects who consume >4 cups of blueberries per week or other foods/drinks with significant polyphenol content

• Subjects supplementing with elderberry syrup >4 times per week

• Subjects who have a planned surgery during the timeline of the study

• Subjects prescribed to antipsychotics

• Subjects using acetaminophen or NSAIDS (drugs targeting pro-inflammatory paths) chronically or exceeding recommended daily doses

• Subjects chronically on Decadron, Dexamethasone, or Prednisone; or other oral steroids

• Subjects on any augmenting agents (the following is not an inclusive list):

Abilify (aripiprazole), Risperdal (risperidone), Zyprexa (olanzapine), Seroquel (quetiapine), Clozaril(clozapine), Symbyax (olanzapine/fluoxetine), Geodon (ziprasidone)

• Subjects supplementing with devil's claw, fenugreek, guar gum, Panax ginseng, and Siberian ginseng

• Subjects who have a history of suicidal ideation or suicide attempt

• Subjects with a history or record of physical violence toward self or others

• Subjects who will jeopardize their job if they miss work for appointments

• Subjects with a history of addiction, except cigarettes

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• Depressive Disorder
• Inflammation

Intervention

Dietary Supplement:
• Freeze Dried Blueberry Powder - 71717
Single serve packets containing 22.5 grams of powdered freeze-dried whole blueberries; A mix of 2 species, Vaccinium virgatum (ashei)/Vaccinium corymbosum, provided by U.S Highbush Blueberry Council (USHBC). Powders are sealed in single serve packets to protect from light and moisture. Packets are refrigerated except for when distributed to participants; participants are asked to store packets in refrigerator until consumption.
• USHBC Blueberry Placebo Formula #114
Blueberry flavor- and color-matched placebo powder.

Locations

Country	Name	City	State
United States	Cottonport Family Clinic	Cottonport	Louisiana
United States	Marksville Family Clinic	Marksville	Louisiana

Sponsors (5)

Lead Sponsor	Collaborator
Louisiana State University, Baton Rouge	Collective Healthcare Solutions, LLC, Louisiana Health Care Practitioners, LLC, U.S. Highbush Blueberry Council, uBiome, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Depression Inventory (MDI)	A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.	Day 1 of treatment intervention, before treatment consumption
Primary	Major Depression Inventory (MDI)	A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.	Day 30 of treatment intervention
Primary	Major Depression Inventory (MDI)	A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.	Day 60 of treatment intervention
Primary	Major Depression Inventory (MDI)	A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.	Day 1 of placebo intervention, before placebo consumption
Primary	Major Depression Inventory (MDI)	A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time and 5=all the time; the higher the score, the more severe the depressive symptom.	Day 30 of placebo intervention
Primary	Major Depression Inventory (MDI)	A brief (10-Item) behavioral survey for assessing clinical depression symptoms and severity; can confirm a DSM-IV diagnosis of depression. The scale spans 0-5 to score "How much of the time..." with 0=at no time, and 5=all the time; the higher the score, the more severe the depressive symptom.	Day 60 of placebo intervention
Primary	Generalized Anxiety Disorder 7-item (GAD-7) scale	A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.	Day 1 of treatment intervention, before treatment consumption
Primary	Generalized Anxiety Disorder 7-item (GAD-7) scale	A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.	Day 30 of treatment intervention
Primary	Generalized Anxiety Disorder 7-item (GAD-7) scale	A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.	Day 60 of treatment intervention
Primary	Generalized Anxiety Disorder 7-item (GAD-7) scale	A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.	Day 1 of placebo intervention, before placebo consumption
Primary	Generalized Anxiety Disorder 7-item (GAD-7) scale	A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.	Day 30 of placebo intervention
Primary	Generalized Anxiety Disorder 7-item (GAD-7) scale	A brief behavioral scale for measuring symptoms related to general anxiety. The scale spans 0-3 to score the frequency of anxiety symptoms with 0=not at all sure and 3=nearly every day; the higher the score, the more frequent the anxiety symptom.	Day 60 of placebo intervention
Primary	Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)	A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.	Day 1 of treatment intervention, before treatment consumption
Primary	Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)	A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.	Day 60 of treatment intervention
Primary	Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)	A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.	Day 1 of placebo intervention, before placebo consumption
Primary	Structured Interview Guide for the Hamilton Depression Scale and Inventory of Depressive Symptomatology-Clinician Rated (SIGHD-IDSC)	A verbal interview probing depressive symptoms based on two separate scales; the Hamilton Depression Scale and the Inventory of Depressive Symptomatology. Scores span 0-4 and are question-specific.	Day 60 of placebo intervention
Secondary	C-Reactive Protein (CRP) Measure	Biological measure of C-Reactive Protein from participant blood sample	Immediately after enrollment, 30 days before start of intervention
Secondary	CRP Measure	Biological measure of C-Reactive Protein from participant blood sample	Day 1 of treatment intervention, before treatment consumption
Secondary	CRP Measure	Biological measure of C-Reactive Protein from participant blood sample	Day 30 of treatment intervention
Secondary	CRP Measure	Biological measure of C-Reactive Protein from participant blood sample	Day 60 of treatment intervention
Secondary	CRP Measure	Biological measure of C-Reactive Protein from participant blood sample	Day 1 of placebo intervention, before placebo consumption
Secondary	CRP Measure	Biological measure of C-Reactive Protein from participant blood sample	Day 30 of placebo intervention
Secondary	CRP Measure	Biological measure of C-Reactive Protein from participant blood sample	Day 60 of placebo intervention
Secondary	Gut Microbiome Analysis	uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome	Day 1 of treatment intervention, before treatment consumption
Secondary	Gut Microbiome Analysis	uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome	Day 30 of treatment intervention
Secondary	Gut Microbiome Analysis	uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome	Day 60 of treatment intervention
Secondary	Gut Microbiome Analysis	uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome	Day 1 of placebo intervention, before placebo consumption
Secondary	Gut Microbiome Analysis	uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome	Day 30 of placebo intervention
Secondary	Gut Microbiome Analysis	uBiome Explorer (TM) Microbiome Sampling Kit; tests microbial communities present in the gut microbiome	Day 60 of placebo intervention
Secondary	Leeds Sleep Evaluation Questionnaire (LSEQ)	A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.	Day 1 of treatment intervention, before treatment consumption
Secondary	Leeds Sleep Evaluation Questionnaire (LSEQ)	A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.	Day 30 of treatment intervention
Secondary	Leeds Sleep Evaluation Questionnaire (LSEQ)	A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.	Day 60 of treatment intervention
Secondary	Leeds Sleep Evaluation Questionnaire (LSEQ)	A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.	Day 1 of placebo intervention, before placebo consumption
Secondary	Leeds Sleep Evaluation Questionnaire (LSEQ)	A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.	Day 30 of placebo intervention
Secondary	Leeds Sleep Evaluation Questionnaire (LSEQ)	A short 10-item survey which probes issues related to sleep including falling asleep, quality and duration of sleep, and waking up after sleep. The scale for each of the 10 items is a line segment on which participants mark a tick; toward one end of the line is worse, toward the other end is better. A discrete datum is extracted from each continuous line by measuring to ticks from one end of the line with a ruler.	Day 60 of placebo intervention
Secondary	Concentration of reactive oxygen species (ROS)	Electron paramagnetic resonance (EPR) to measures reactive oxygen species (ROS) in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of reactive oxygen species (ROS)	Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples	Day 30 of treatment intervention
Secondary	Concentration of reactive oxygen species (ROS)	Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples	Day 60 of treatment intervention
Secondary	Concentration of reactive oxygen species (ROS)	Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of reactive oxygen species (ROS)	Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples	Day 30 of placebo intervention
Secondary	Concentration of reactive oxygen species (ROS)	Electron paramagnetic resonance (EPR) measures reactive oxygen species (ROS) in participant blood samples	Day 60 of placebo intervention
Secondary	Concentration of quinolinic acid	Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of quinolinic acid	Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples	Day 30 of treatment intervention
Secondary	Concentration of quinolinic acid	Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples	Day 60 of treatment intervention
Secondary	Concentration of quinolinic acid	Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of quinolinic acid	Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples	Day 30 of placebo intervention
Secondary	Concentration of quinolinic acid	Enzyme-linked immunosorbent assay (ELISA) to measure quinolinic acid in participant blood samples	Day 60 of placebo intervention
Secondary	Concentration of kynurenic acid	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of kynurenic acid	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples	Day 30 of treatment intervention
Secondary	Concentration of kynurenic acid	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples	Day 60 of treatment intervention
Secondary	Concentration of kynurenic acid	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of kynurenic acid	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples	Day 30 of placebo intervention
Secondary	Concentration of kynurenic acid	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenic acid in participant blood samples	Day 60 of placebo intervention
Secondary	Concentration of kynurenine	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of kynurenine	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples	Day 30 of treatment intervention
Secondary	Concentration of kynurenine	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples	Day 60 of treatment intervention
Secondary	Concentration of kynurenine	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of kynurenine	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples	Day 30 of placebo intervention
Secondary	Concentration of kynurenine	Enzyme-linked immunosorbent assay (ELISA) to measure kynurenine in participant blood samples	Day 60 of placebo intervention
Secondary	Concentration of tryptophan	Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of tryptophan	Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples	Day 30 of treatment intervention
Secondary	Concentration of tryptophan	Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples	Day 60 of treatment intervention
Secondary	Concentration of tryptophan	Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of tryptophan	Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples	Day 30 of placebo intervention
Secondary	Concentration of tryptophan	Enzyme-linked immunosorbent assay (ELISA) to measure tryptophan in participant blood samples	Day 60 of placebo intervention
Secondary	Concentration of indoleamine 2,3-dioxygenase (IDO)	Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of indoleamine 2,3-dioxygenase (IDO)	Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples	Day 30 of treatment intervention
Secondary	Concentration of indoleamine 2,3-dioxygenase (IDO)	Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples	Day 60 of treatment intervention
Secondary	Concentration of indoleamine 2,3-dioxygenase (IDO)	Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of indoleamine 2,3-dioxygenase (IDO)	Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples	Day 30 of placebo intervention
Secondary	Concentration of indoleamine 2,3-dioxygenase (IDO)	Enzyme-linked immunosorbent assay (ELISA) to measure indoleamine 2,3-dioxygenase (IDO) in participant blood samples	Day 60 of placebo intervention
Secondary	Concentration suicide-associated protein spindle and kinetochore-associated protein 2 (SKA-2)	Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of suicide-associated protein SKA-2	Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples	Day 30 of treatment intervention
Secondary	Concentration of suicide-associated protein SKA-2	Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples	Day 60 of treatment intervention
Secondary	Concentration of suicide-associated protein SKA-2	Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of suicide-associated protein SKA-2	Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples	Day 30 of placebo intervention
Secondary	Concentration of suicide-associated protein SKA-2	Enzyme-linked immunosorbent assay (ELISA) to measure SKA-2 in participant blood samples	Day 60 of placebo intervention
Secondary	Concentration of suicide-associated protein spermidine/spermine N1-acetyltransferase 1 (SAT-1)	Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of suicide-associated protein SAT-1	Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples	Day 30 of treatment intervention
Secondary	Concentration of suicide-associated protein SAT-1	Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples	Day 60 of treatment intervention
Secondary	Concentration of suicide-associated protein SAT-1	Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of suicide-associated protein SAT-1	Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples	Day 30 of placebo intervention
Secondary	Concentration of suicide-associated protein SAT-1	Enzyme-linked immunosorbent assay (ELISA) to measure SAT-1 in participant blood samples	Day 60 of placebo intervention
Secondary	Concentration of suicide-associated protein solute carrier family 4 member 4 (SLC4A4)	Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of suicide-associated protein SLC4A4	Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples	Day 30 of treatment intervention
Secondary	Concentration of suicide-associated protein SLC4A4	Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples	Day 60 of treatment intervention
Secondary	Concentration of suicide-associated protein SLC4A4	Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of suicide-associated protein SLC4A4	Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples	Day 30 of placebo intervention
Secondary	Concentration of suicide-associated protein SLC4A4	Enzyme-linked immunosorbent assay (ELISA) to measure SLC4A4 in participant blood samples	Day 60 of placebo intervention
Secondary	Concentration of brain-derived neurotropic factor (BDNF)	Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of brain-derived neurotropic factor (BDNF)	Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples	Day 30 of treatment intervention
Secondary	Concentration of brain-derived neurotropic factor (BDNF)	Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples	Day 60 of treatment intervention
Secondary	Concentration of brain-derived neurotropic factor (BDNF)	Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of brain-derived neurotropic factor (BDNF)	Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples	Day 30 of placebo intervention
Secondary	Concentration of brain-derived neurotropic factor (BDNF)	Enzyme-linked immunosorbent assay (ELISA) to measure brain-derived neurotropic factor (BDNF) in participant plasma samples	Day 60 of placebo intervention
Secondary	Concentration of glial cell line-derived neurotropic factor (GDNF)	Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of glial cell line-derived neurotropic factor (GDNF)	Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples	Day 30 of treatment intervention
Secondary	Concentration of glial cell line-derived neurotropic factor (GDNF)	Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples	Day 60 of treatment intervention
Secondary	Concentration of glial cell line-derived neurotropic factor (GDNF)	Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples	Day 1 of placebo intervention, before placebo intervention
Secondary	Concentration of glial cell line-derived neurotropic factor (GDNF)	Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples	Day 30 of placebo intervention
Secondary	Concentration of glial cell line-derived neurotropic factor (GDNF)	Enzyme-linked immunosorbent assay (ELISA) to measure glial cell line-derived neurotropic factor (GDNF) in participant plasma samples	Day 60 of placebo intervention
Secondary	Concentration of serotonin related compound serotonin transporter (SERT)	Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of serotonin related compound SERT	Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples	Day 30 of treatment intervention
Secondary	Concentration of serotonin related compound SERT	Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples	Day 60 of treatment intervention
Secondary	Concentration of serotonin related compound SERT	Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of serotonin related compound SERT	Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples	Day 30 of placebo intervention
Secondary	Concentration of serotonin related compound SERT	Enzyme-linked immunosorbent assay (ELISA) to measure serotonin transporter (SERT) in participant blood samples	Day 60 of placebo intervention
Secondary	Concentration of serotonin related compound 5-hydroxyindoleacetic acid (5-HIAA)	Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of serotonin related compound 5-HIAA	Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples	Day 30 of treatment intervention
Secondary	Concentration of serotonin related compound 5-HIAA	Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples	Day 60 of treatment intervention
Secondary	Concentration of serotonin related compound 5-HIAA	Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of serotonin related compound 5-HIAA	Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples	Day 30 of placebo intervention
Secondary	Concentration of serotonin related compound 5-HIAA	Enzyme-linked immunosorbent assay (ELISA) to measure 5-hydroxyindoleacetic acid (5-HIAA) in participant blood samples	Day 60 of placebo intervention
Secondary	Concentration of glutamate	Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of glutamate	Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples	Day 30 of treatment intervention
Secondary	Concentration of glutamate	Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples	Day 60 of treatment intervention
Secondary	Concentration of glutamate	Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of glutamate	Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples	Day 30 of placebo intervention
Secondary	Concentration of glutamate	Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamate in participant blood samples	Day 60 of placebo intervention
Secondary	Concentration of glutamine	Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of glutamine	Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples	Day 30 of treatment intervention
Secondary	Concentration of glutamine	Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples	Day 60 of treatment intervention
Secondary	Concentration of glutamine	Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of glutamine	Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples	Day 30 of placebo intervention
Secondary	Concentration of glutamine	Enzyme-linked immunosorbent assay (ELISA) to measure concentration of glutamine in participant blood samples	Day 60 of placebo intervention
Secondary	Concentration of cortisol	Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of cortisol	Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples	Day 30 of treatment intervention
Secondary	Concentration of cortisol	Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples	Day 60 of treatment intervention
Secondary	Concentration of cortisol	Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of cortisol	Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples	Day 30 of placebo intervention
Secondary	Concentration of cortisol	Enzyme-linked immunosorbent assay (ELISA) to measure concentration of cortisol in participant blood samples	Day 60 of placebo intervention
Secondary	Concentration of inflammation biomarker interleukin 6 (IL-6)	Luminex assay to measure interleukin 6 (IL-6) in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of inflammation biomarker interleukin 6 (IL-6)	Luminex assay to measure interleukin 6 (IL-6) in participant blood samples	Day 30 of treatment intervention
Secondary	Concentration of inflammation biomarker interleukin 6 (IL-6)	Luminex assay to measure interleukin 6 (IL-6) in participant blood samples	Day 60 of treatment intervention
Secondary	Concentration of inflammation biomarker interleukin 6 (IL-6)	Luminex assay to measure interleukin 6 (IL-6) in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of inflammation biomarker interleukin 6 (IL-6)	Luminex assay to measure interleukin 6 (IL-6) in participant blood samples	Day 30 of placebo intervention
Secondary	Concentration of inflammation biomarker interleukin 6 (IL-6)	Luminex assay to measure interleukin 6 (IL-6) in participant blood samples	Day 60 of placebo intervention
Secondary	Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)	Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)	Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples	Day 30 of treatment intervention
Secondary	Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)	Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples	Day 60 of treatment intervention
Secondary	Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)	Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)	Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples	Day 30 of placebo intervention
Secondary	Concentration of inflammation biomarker interleukin 1 beta (IL-1beta)	Luminex assay to measure interleukin 1 beta (IL-1beta) in participant blood samples	Day 60 of placebo intervention
Secondary	Concentration of inflammation biomarker interferon gamma (IFN-gamma)	Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of inflammation biomarker interferon gamma (IFN-gamma)	Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples	Day 30 of treatment intervention
Secondary	Concentration of inflammation biomarker interferon gamma (IFN-gamma)	Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples	Day 60 of treatment intervention
Secondary	Concentration of inflammation biomarker interferon gamma (IFN-gamma)	Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of inflammation biomarker interferon gamma (IFN-gamma)	Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples	Day 30 of placebo intervention
Secondary	Concentration of inflammation biomarker interferon gamma (IFN-gamma)	Luminex assay to measure interferon gamma (IFN-gamma) in participant blood samples	Day 60 of placebo intervention
Secondary	Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)	Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples	Day 1 of treatment intervention, before treatment consumption
Secondary	Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)	Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples	Day 30 of treatment intervention
Secondary	Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)	Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples	Day 60 of treatment intervention
Secondary	Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)	Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples	Day 1 of placebo intervention, before placebo consumption
Secondary	Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)	Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples	Day 30 of placebo intervention
Secondary	Concentration of inflammation biomarker tumour necrosis factor alpha (TNF-alpha)	Luminex assay to measure tumour necrosis factor alpha (TNF-alpha) in participant blood samples	Day 60 of placebo intervention