NCT06058364

Effect of a Nutritional Supplement on Mental Wellness in Adults

Completed NA Last updated 7 November 2024

What this trial tests

NA trial testing Intervention 1 - Triglyceride in Low Mood in 150 participants. Completed in 8 October 2024.

Timeline

18 September 2023

Primary endpoint
24 May 2024

8 October 2024

Quick facts

Lead sponsor	Pharmavite LLC
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	150
Start date	18 September 2023
Primary completion	24 May 2024
Estimated completion	8 October 2024
Sites	1 location across United States

Drugs / interventions tested

• Intervention 1 - Triglyceride
• Intervention 2 - Placebo

Conditions studied

• Low Mood — all drugs for Low Mood →

Sponsor

Pharmavite LLC — full company profile →

Who can join

Adults 18 to 65, any sex, with Low Mood. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Predispose, precipitate, perpetuate, and protect: how diet and the gut influence mental health in emerging adulthood.
   Warren M, O'Connor C, Lee JE, Burton J, et al · · 2024 · cited 5× · PMID 38505265 · DOI 10.3389/fnut.2024.1339269