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COMPLETED NA

Effect of a Nutritional Supplement on Mental Wellness in Adults

NCT06058364 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 150 participants
Start Date 2023-09-18
Est. Completion 2024-10-08
Phase NA

Sponsor

Pharmavite

2 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06058364 reports 1 study location spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06058364?

The interventions under investigation include: Intervention 1 - Triglyceride (DIETARY_SUPPLEMENT), Intervention 2 - Placebo (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06058364?

This trial is sponsored by Pharmavite, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial