Colostrum and Gut Health

Conditions

• Gastrointestinal Health

Eligibility Criteria

Sex

ALL

Age

30 Years - 60 Years

Healthy Volunteers

Accepted

Interventions

• Bovine Colostrum - Lower Dose — DIETARY_SUPPLEMENT
  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 — DIETARY_SUPPLEMENT
  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 — DIETARY_SUPPLEMENT
  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.

Study Details

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.

Key Dates

First listed

Oct 5, 2026

Start date

Sep 4, 2026

Status verified

Sep 2026

Primary completion

Jul 1, 2028

Completion

Sep 1, 2028

Study Design

Enrollment

140 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: Lower Dose Bovine Colostrum
  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.
• Experimental: Higher-Dose Bovine Colostrum
  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 Comparator: 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.

Primary Outcome Measure

Change in Gastrointestinal Function Assessed by the PROMIS Gastrointestinal Combined Short Form [ Time Frame: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20 ]

Central Contacts

• Chad Kerksick, PhD
  650-206-8006
  [email protected]

Locations (1)

Find similar trials in San Francisco, CA

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