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NOT YET RECRUITING
NCT07856979
NA

Colostrum and Gut Health

Sponsor: Bovita Labs, LLC

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate changes in participant-reported gastrointestinal function over a 16-week intervention period and a 4-week non-supplementation period (20 weeks total) following daily consumption of two different doses of colostrum in comparison to a placebo. Secondary objectives include evaluation of digestive comfort, immune resilience, energy levels, sleep quality, hsCRP, metabolic panel, microbiome status and function, and hair and skin health. Exploratory objectives include the collection of physical activity status and pulse rate variability at specified timepoints to provide supportive contextual information alongside participant-reported outcomes.

Official title: A Randomized Controlled Trial to Examine the Impact of Two Colostrum Doses on Gut Health

Key Details

Gender

All

Age Range

30 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-09-04

Completion Date

2028-09-01

Last Updated

2026-10-05

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Bovine Colostrum - Lower Dose

Participants randomized to this group will consume the protocol-defined lower dose of bovine colostrum once daily with food for 16 weeks, followed by a 4-week non-supplementation period.

DIETARY_SUPPLEMENT

Bovine Colostrum - Higher Dose

Participants randomized to this group will consume the protocol-defined higher dose of bovine colostrum once daily with food for 16 weeks, followed by a 4-week non-supplementation period.

DIETARY_SUPPLEMENT

Placebo

Participants randomized to this group will consume a matched placebo once daily with food for 16 weeks, followed by a 4-week non-supplementation period.

Locations (1)

Alethios, Inc.

San Francisco, California, United States