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.
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.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | December 2, 2024 |
| Est. primary completion date | May 24, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: To be eligible for inclusion, the Participant must fulfil all the following criteria: 1. Be willing to participate in the study and comply with its procedures. 2. Be able to give written informed consent. 3. Adults aged between 18 and 65 years (inclusive). 4. Participants with a BMI between =18.5 and <30.0 kg/m^2. 5. Has self-reported mild-moderate low mood, confirmed by a Hospital Anxiety and Depression Scale (HADS - D) score 8 - 14. 6. Be willing to maintain stable dietary habits and physical activity levels throughout the study period. 7. Be able to communicate well with the Investigator, to understand and comply with the requirements of the study and be judged suitable for the study in the opinion of the Investigator. Exclusion Criteria: Participants will be excluded from the study if they meet any of the following criteria: 1. Recent use of probiotics, prebiotics, postbiotic and other fermented foods that contain live bacteria within last 30 days from Visit 2. 2. Recent use of any dietary supplements, within last 14 days from Visit 2. 3. Participant who has been on antibiotics during the 90 days from Visit 2. 4. Participant with a malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by Investigators to be risky or that could interfere with data collection. 5. Participants who have started receiving cognitive behavioural therapy (CBT) or psychotherapy in the last 90 days prior to Visit 2 or plan to start during the period of the study. 6. Participant who is severely immunocompromised (HIV positive, transplant patient, on anti-rejection medications, on a systemic steroid treatment for >30 days, or chemotherapy or radiotherapy within the last year). 7. Significant psychiatric diagnosis (e.g., bipolar), as diagnosed by a healthcare professional, including major depressive disorder (e.g., clinical depression) and anxiety disorder. 8. Participants taking anti-depressants or herbal treatments for mood disorders or psychological conditions (e.g., valerian, St. John's Wort) within 90 days prior to Visit 2 or planning to start during the study period. 9. Participants who are on anxiolytics, antipsychotics, anticonvulsants, antidepressants, opioid pain relievers, hypnotics, and/or prescribed sleep medication within 30 days prior to screening (Visit 1). 10. Participants with a current history of drug (including illicit drug) and /or alcohol abuse at the time of enrolment. 11. Participants who consume any products containing Tetrahydrocannabinol (THC) and Cannabidiol (CBD) 30 days prior to screening (Visit 1). 12. Participants who are unwilling to only consume butter or margarine once per day for the duration of the study. 13. Participants with a fiber intake of >18g/day 14. Participants who are pregnant (determined by urine pregnancy test for all individuals of childbearing potential at screening, regardless of contraceptive use or relationship status), breastfeeding, or wish to become pregnant during the study. 15. Have an acute or chronic illness (e.g., heart disease, uncontrolled hypertension, uncontrolled hypercholesterolemia, inflammatory bowel disease, cancer, HIV) that, in the Investigators judgment, precludes involvement in the study. 16. Have had any other condition or are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of the study results. 17. Change in prescribed medication, or major diet change in the 30 days prior to enrolment (Visit 2). 18. Has received treatment involving experimental drugs in the past 90 days and experimental supplements in the past 60 days at the discretion of the investigator. 19. Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Atlantia Clinical Trials | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Pharmavite LLC | Atlantia Food Clinical Trials |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | To evaluate the effect of consumption of triglyceride supplement compared to Placebo in a population with self-reported low mood with mild to moderate symptoms on fat mass measured by dual X-ray absorptiometry (DEXA) | A change from baseline to week 8 in fat mass as a percentage of total mass (%). | From baseline to 8 weeks | |
| Other | To evaluate the effect of consumption of triglyceride supplement compared to Placebo in a population with self-reported low mood with mild to moderate symptoms on gut microbial composition | A change from baseline to week 8 in gut microbial composition as determined by shot gun sequencing of fecal DNA | From baseline to 8 weeks | |
| Primary | To evaluate the effect of eight weeks consumption of triglyceride supplement compared to Placebo on low mood in a population with self-reported mild to moderate symptoms (Hospital Anxiety and Depression Scale - Depression, HADS-D score of 8 - 14). | A change in self-reported symptoms of low mood assessed by Hospital Anxiety and Depression Scale - Depression (HADS-D) at baseline to week 8. HADS-D sub-score ranges from 0 - 21, where higher score is worse. | From baseline to Week 8 | |
| Secondary | To evaluate the effect of consumption of triglyceride supplement compared to Placebo on low mood, in a population with self-reported mild to moderate symptoms (Hospital Anxiety and Depression Scale - Depression (HADS-D) score of 8 - 14). | A change from baseline to week 2 and week 4, in self-reported mild to moderate symptoms assessed by Hospital Anxiety and Depression Scale, HADS Depression sub score (HADS-D), .which ranges from 0 - 21 and higher score is worse. | From baseline to week 2 and week 4 | |
| Secondary | To evaluate the effect of consumption of triglyceride supplement compared to Placebo in a population with self-reported low mood with mild to moderate symptoms on anxiety. | A change from baseline to weeks 2, 4 and 8 in self-reported anxiety assessed by Hospital Anxiety and Depression Scale, HADS anxiety sub score (HADS-A).HADS-A sub score range from 0 - 21, where higher score is worse. | From baseline to weeks 2, 4 and 8 | |
| Secondary | To evaluate the effect of consumption of triglyceride supplement compared to Placebo in a population with self-reported low mood with mild to moderate symptoms on sleep using Motionlogger Micro Watch (Sleep Watch) and Karolinska Sleepiness Scale (KSS). | A change from baseline to weeks 2, 4 and 8 in activity index score recorded by Sleep Watch.
A change from baseline to weeks 2, 4 and 8 in total duration in bed (min) recorded by Sleep Watch. A change from baseline to weeks 2, 4 and 8 in latency to persistent sleep (min) recorded by Sleep Watch. A change from baseline to weeks 2, 4 and 8 in sleep efficiency (%) recorded by Sleep Watch. A change from baseline to weeks 2, 4 and 8 in sleep fragmentation (events/h) recorded by Sleep Watch. A change from baseline to weeks 2, 4 and 8 in sleep minutes (min) recorded by Sleep Watch. A change from baseline to weeks 2, 4 and 8 in wake after sleep onset (WASO) (min) recorded by Sleep Watch. A change from baseline to weeks 2, 4 and 8 in perceived awakening refreshed level assessed by Karolinska Sleepiness Scale (KSS) Score for waking up refreshed. KSS is a 9 point scale (1 - 9), where 1 = extremely alert and 9 = extremely sleepy) |
From baseline to weeks 2, 4 and 8 | |
| Secondary | To evaluate the effect of consumption of triglyceride supplement compared to Placebo in a population with self-reported low mood with mild to moderate symptoms on general health, physical functioning and energy | Short -Form 36 score ranges from 0 - 100. Higher scores indicate higher quality of life.
A change from baseline to weeks 2, 4 and 8 in quality of life as measured by Short-Form 36 general health scale. A change from baseline to weeks 2, 4 and 8 in quality of life as measured by Short-Form 36 physical functioning scale. A change from baseline to 4 and 8 in quality of life as measured by Short-Form 36 energy/fatigue scale. |
From baseline to weeks 2, 4 and 8 or weeks 4 and 8 | |
| Secondary | To evaluate the effect of consumption of triglyceride supplement compared to Placebo in a population with self-reported low mood with mild to moderate symptoms on Stress | A change from baseline to weeks 4 and 8 in perceived stress level assessed by Cohen's Perceived Stress Scale (PSS). Cohen's Perceived Stress Scale ranges from 0 - 40. Higher scores indicate greater perceived stress levels. | From baseline to weeks 4 and 8 | |
| Secondary | To evaluate the effect of consumption of triglyceride supplement compared to Placebo in a population with self-reported low mood with mild to moderate symptoms on salivary cortisol | A change from baseline to weeks 2, 4 and 8 in salivary cortisol (nmol/L) from T0 to post awakening samples T30
A change from baseline to weeks 2, 4 and 8 in salivary cortisol (nmol/L) from T0 to post awakening samples T45 A change from baseline to weeks 2, 4 and 8 in salivary cortisol (nmol/L) from T0 to post awakening samples T60 A change from baseline to weeks 2, 4 and 8 in salivary cortisol (nmol/L) awakening response (CAR) as measured by Area Under the Curve (AUC) (T0, T30, T45, T60). |
From baseline to weeks 2, 4 and 8 |
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