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Effect of a Nutritional Supplement on Mental Wellness in Adults

NCT06058364 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-11-07

No results posted yet for this 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

  • Low Mood

Interventions

DIETARY_SUPPLEMENT

Intervention 1 - Triglyceride

Triglyceride (1 softgel each morning with a glass of water)

DIETARY_SUPPLEMENT

Intervention 2 - Placebo

Placebo (1 softgel each morning with a glass of water)

Sponsors & Collaborators

  • Atlantia Food Clinical Trials

    collaborator INDUSTRY

  • Pharmavite LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-18
Primary Completion
2024-05-24
Completion
2024-10-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06058364 on ClinicalTrials.gov