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NCT06058364 · ClinicalTrials.gov registry record · NA
Effect of a Nutritional Supplement on Mental Wellness in Adults
A NA study of Low Mood, sponsored by Pharmavite.
- Completed
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT06058364: Completed NA study of Low Mood, sponsored by Pharmavite.
NCT06058364 is a NA study of Low Mood that has completed, run by Pharmavite. The registered enrollment target is 150 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06058364, a NA study of Low Mood, has completed, sponsored by Pharmavite.
- COMPLETED
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Intervention 1 - Triglyceride
- DIETARY_SUPPLEMENT Intervention 2 - Placebo
Study Locations (1)
Illinois
- Atlantia Clinical Trials - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-09-18 |
| Est. Completion | 2024-10-08 |
| Phase | NA |
What the finished NCT06058364 record still lists
NCT06058364 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Low Mood appearing as the primary indexed condition, and to 2 interventions - of which Intervention 1 - Triglyceride is the first listed.
NCT06058364 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06058364 about?
NCT06058364 is a clinical study titled "Effect of a Nutritional Supplement on Mental Wellness in Adults". 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 b...
What is the current status of trial NCT06058364?
This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2023-09-18. Estimated completion is 2024-10-08.
What conditions does trial NCT06058364 study?
This clinical trial studies the following conditions: Low Mood.
What interventions are being tested in trial NCT06058364?
The interventions under investigation include: Intervention 1 - Triglyceride (DIETARY_SUPPLEMENT), Intervention 2 - Placebo (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06058364?
This trial is sponsored by Pharmavite, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06058364 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06058364's enrollment target sits among peer trials
150 661st of 2000 higher than 1,299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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