Effect of a Nutritional Supplement on Mental Wellness in Adults

Low Mood Clinical Trial

Official title: A Randomized, Double Blind, Placebo Controlled Parallel Study to Assess the Effects of a Triglyceride on Adults With Low to Moderately Low Mood.

Status Recruiting

Clinical Trial Summary

Trillions of microbes reside in human gut and constitute "gut microbiota". Composition of these microbes and substances produced by them play an important role in human health and wellness.

The goal of this study is to determine if a unique orally consumed triglyceride supplement will impart mood benefits. Investigators hypothesize that a part of the fatty acids will be released in upper gastrointestinal (GI) tract and can be absorbed and reach different organs via systemic circulation (blood), including to the brain, and provide health benefits. Rest of the portion would reach the colon and may modulate gut microbiota and provide health benefits via the gut-brain axis (a bi-directional communication between emotional and cognitive centers and the gastrointestinal system). These health benefits could include alleviation of stress, occasional anxiousness and low mood.

Participants with self-reported low mood will be randomized to two groups - one group will receive triglyceride supplement in softgel form and another group will receive a placebo (softgel with no active substance). Investigators will evaluate the effect of consumption of triglyceride supplement compared to Placebo on occasional low mood, occasional anxiousness, stress, sleep and general health by measuring changes from baseline.

Clinical Trial Description

This is a randomized, placebo-controlled, double-blind, parallel study, which will include 5 visits over 10 week period - a screening visit (Visit 1; week -3), a 3-week run-in period followed by baseline determination or baseline visit (Visit 2; day 0), and three test visits (Visits 3, 4, and 5 at days 14, 28, and 56 respectively).

SCREENING

Visit 1 - Week -3

At Visit 1 (Screening visit) Participants will attend the study site and the following procedures will be carried out:

• Participants will receive oral and written information about the study and be allowed to ask questions.

• Participants will sign the informed consent document.

• Inclusion and exclusion criteria will be reviewed.

• Demographic, health, and lifestyle data will be collected.

• Medical history will be collected.

• Concomitant medication will be recorded.

• Height and weight will be measured, and Body Mass Index (BMI) calculated.

• Vitals (blood pressure, heart rate and temperature) will be recorded.

• Complete Block Fiber screener

• Download the Electronic Patient Reported Outcomes (ePRO) questionnaire app to the participants device.

• Complete Hospital Anxiety and Depression (HADS) questionnaire.

• A blood sample will be collected for screening and safety analysis.

• For participants of childbearing potential, a urine sample will be collected, and pregnancy test performed (regardless of contraceptive use or relationship status).

• Participants will be provided with a stool collection kit and instructions for collecting and storing their sample. Participants will collect a stool sample at home, within 48 hours of their scheduled visit and bring it to the clinic at their next visit.

• Participants will be provided with a saliva collection kit and instructions for collecting and storing their sample. Participants will collect a saliva sample at home, at T0, T30, T45, T60 minutes after waking on the morning of their scheduled visit and bring it to the clinic at their visit.

• Participants will be provided with the Karolinska Sleepiness Scale (KSS). Participants will complete this 5 minutes after collecting T0 saliva sample on the morning of their scheduled visit and bring it to the clinic at their visit.

• Participants will be provided with a 3-day food diary and instructions on how to complete the document. Participants will return their completed diary at their next visit.

• Participants will be reminded to complete the questionnaires with 24 hours of their next visit.

• Participants will be provided with a provisional appointment to attend a Dual X-ray absorptiometry (DEXA) scan.

Participants will be given an appointment to return to the study site within 21 days for their baseline/day 1 visit.

INTERVENTION PHASE

Visit 2 - Day 0

Participants will complete a dual X-ray absorptiometry (DEXA) scan in advance of taking their first dose of study product, between Day -21 and Day 0.

Participants will attend this study visit and the following procedures will be carried out:

• Participant's continued consent to study procedures will be confirmed.

• Inclusion/exclusion criteria will be reviewed.

• Adverse events will be recorded.

• Concomitant medication/supplements will be recorded.

• Weight will be measured, and BMI calculated.

• Vitals (blood pressure, heart rate and temperature) will be recorded.

• For individuals of childbearing potential, a urine sample will be collected, and pregnancy test performed (regardless of contraceptive use or relationship status).

• Participants will return their saliva samples and samples will be stored for future analysis.

• Participants will return their stool sample and sample will be stored for future analysis.

• Participants will return their completed 3-day food diary.

• Participants will return their completed Karolinska Sleepiness Scale (KSS) questionnaire.

• Participants will have completed the following questionnaires within 24 hours of the visit:

• Cohen's Perceived Stress Scale (PSS)

• 36 item short form survey (SF-36)

• Complete Hospital Anxiety and Depression (HADS) questionnaire.

• A blood sample will be collected and stored for future biomarker analysis.

• Participants will be provided with a stool collection kit and instructions for collecting and storing their sample. Participants will collect a stool sample at home, within 48 hours of their scheduled visit and bring it to the clinic at their next visit.

• Participants will be provided with a saliva collection kit and instructions for collecting and storing their sample. Participants will collect a saliva sample at home, at T0, T30, T45, T60 minutes after waking on the morning of their scheduled visit and bring it to the clinic at their visit.

• Participants will be provided with the Karolinska Sleepiness Scale (KSS). Participants will complete this 5 minutes after collecting T0 saliva sample on the morning of their scheduled visit and bring it to the clinic at their visit.

• Participants will be reminded to complete the questionnaires with 24 hours of their next visit.

• Participants will be provided with a watch for monitoring their sleep and instructions for how to wear and use the watch.

Participants will be randomized into one of two treatment groups as follows, but will be blinded as to which group, they are in:

• Group 1: Triglyceride supplement

• Group 2: Placebo

Participants will be supplied with an 8-week supply of study product and instructions of dosing. Participants will be instructed to take one soft-gel capsule each day for the next eight weeks. An additional eight days of doses will be supplied in case of delay of study visit or loss of study product.

• Participants will be provided with an appointment to return to the study site in two weeks.

Visit 3 - Day 14

Participants will return to the study site at day 14 and the following procedures will be carried out:

• Participant's continued consent to study procedures will be confirmed.

• Adverse events will be recorded.

• Concomitant medication/supplements will be recorded.

• Data from the Participant's sleep watch will be reviewed and battery for the watch will be replaced.

• Participants will return their saliva samples and samples will be stored for future analysis.

• Participants will return their stool sample and sample will be stored for future analysis.

• Participants will return their completed KSS questionnaire.

• Participants will have completed the following questionnaires within 24 hours of the visit:

• 36 item short form survey (SF-36)

• Complete Hospital Anxiety and Depression, HADS questionnaire.

• A blood sample will be collected and stored for future biomarker analysis.

• Participants will be provided with a stool collection kit and instructions for collecting and storing their sample. Participants will collect a stool sample at home, within 48 hours of their scheduled visit and bring it to the clinic at their next visit.

• Participants will be provided with a saliva collection kit and instructions for collecting and storing their sample. Participants will collect a saliva sample at home, at T0, T30, T45, T60 minutes after waking on the morning of their scheduled visit and bring it to the clinic at their visit.

• Participants will be provided with the Karolinska Sleepiness Scale (KSS). Participants will complete this 5 minutes after collecting T0 saliva sample on the morning of their scheduled visit and bring it to the clinic at their visit.

• Participants will be reminded to complete the questionnaires with 24 hours of their next visit.

• Participants will be provided with an appointment to return to the study site in two weeks.

Visit 4 - Day 28

Participants will return to the study site at day 28 and the following procedures will be carried out:

• Participant's continued consent to study procedures will be confirmed.

• Adverse events will be recorded.

• Concomitant medication/supplements will be recorded.

• Data from the Participant's sleep watch will be reviewed and battery for the watch will be replaced.

• Participants will return their saliva samples and samples will be stored for future analysis.

• Participants will return their stool sample and sample will be stored for future analysis.

• Participants will return their completed Karolinska Sleepiness Scale (KSS) questionnaire.

• Participants will have completed the following questionnaires within 24 hours of the visit:

• Cohen's Perceived Stress Scale (PSS)

• 36 item short form survey (SF-36)

• Complete Hospital Anxiety and depression (HADS) questionnaire.

• A blood sample will be collected and stored for future biomarker analysis.

• Participants will be provided with a stool collection kit and instructions for collecting and storing their sample. Participants will collect a stool sample at home, within 48 hours of their scheduled visit and bring it to the clinic at their next visit.

• Participants will be provided with a saliva collection kit and instructions for collecting and storing their sample. Participants will collect a saliva sample at home, at T0, T30, T45, T60 minutes after waking on the morning of their scheduled visit and bring it to the clinic at their visit.

• Participants will be provided with the Karolinska Sleepiness Scale (KSS). Participants will complete this 5 minutes after collecting T0 saliva sample on the morning of their scheduled visit and bring it to the clinic at their visit.

• Participants will be reminded to complete the questionnaires with 24 hours of their next visit.

• Participants will be provided with a 3-day food diary and instructions on how to complete the document. Participants will return their completed diary at their next visit.

• Participants will be provided with an appointment to return to the study site in two weeks.

Visit 5 (Final Visit) - Day 56

Participants will return to the study site at day 56 and the following procedures will be carried out:

• Adverse events will be recorded.

• Concomitant medication/supplements will be recorded.

• Participants will return any unused study product and compliance will be assessed.

• Participants will return their sleep watch and the data from the Participant's sleep watch will be reviewed.

• Participants will return their saliva samples and samples will be stored for future analysis.

• Participants will return their stool sample and sample will be stored for future analysis.

• Participants will return their 3-day food diary.

• Participants will return their completed Karolinska Sleepiness Scale (KSS) questionnaire.

• Weight will be measured, and BMI calculated.

• Vitals (blood pressure, heart rate and temperature) will be recorded.

• Participants will have completed the following questionnaires within 24 hours of the visit:

• Cohen's Perceived Stress Scale (PSS)

• 36 item short form survey (SF-36)

• Complete Hospital Anxiety and Depression (HADS) questionnaire.

• The questionnaire data will be reviewed, and the app deleted from the participants device.

• A blood sample will be collected for safety analysis.

• A blood sample will be collected and stored for future biomarker analysis.

• For participants of childbearing potential, a urine sample will be collected, and pregnancy test performed (regardless of contraceptive use or relationship status)

• Participants will attend a DEXA scan 0 to 7 days after Visit 5. ;

Related Conditions & MeSH terms

• Depression
• Low Mood

• NCT number: NCT06058364
• Study type: Interventional
• Source: Pharmavite LLC
• Contact: Kevin O'Regan, Operations Manager
• Phone: 312 535 9440
• Email: koregan@atlantiatrials.com
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2023
• Completion date: December 2, 2024