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Colostrum and Gut Health
Sponsor: Bovita Labs, LLC
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
Conditions
Interventions
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.
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.
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