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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 is a NA study of Low Mood that has completed, run by Pharmavite. The registered enrollment target is 150 participants. The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06058364
The ClinicalTrials.gov registry entry for NCT06058364 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pharmavite, which has 5 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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