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.
Study 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.
Eligibility
Sex
ALL
Min age
30 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Adults aged 30 to 60 years at the time of enrollment.
* Self-reported suboptimal digestive function (e.g., bloating, irregular bowel habits, discomfort) and/or suboptimal immune function (e.g., frequent colds, low energy) during the previous 4 weeks.
* Willing and able to consume a powdered supplement (3-6 g) mixed in liquid once daily.
* Own a compatible iOS or Android smartphone with internet access.
* Willing to connect a compatible wearable device (Apple Watch or Oura Ring) or Apple Health/Google Fit data source for passive data collection.
* Complete at least 30 minutes of physical activity or exercise most days of the week.
* Able to provide informed consent and comply with the study protocol for 20 weeks.
* Able to read and understand English.
* Willing to provide informed consent electronically.
Exclusion Criteria:
* Diagnosis of inflammatory bowel disease, Crohn's disease, ulcerative colitis, or other malabsorptive gastrointestinal disease or condition.
* Diagnosis of celiac disease or known severe allergy to dairy-derived or bovine colostrum products.
* Currently pregnant, breastfeeding, or planning pregnancy during the study period.
* Current or within the previous 30 days use of immunosuppressive medications, systemic corticosteroids, or biologic agents.
* Use of bovine colostrum or colostrum-containing supplements within the previous 30 days.
* Regular use of probiotic or prebiotic supplements within 14 days of enrollment. Does not participate in at least 30 minutes of physical activity or exercise most days of the week.
* Major gastrointestinal surgery within the previous 12 months.
* Autoimmune condition requiring immunomodulatory treatment.
* Participation in another interventional clinical study within 30 days of enrollment.
* Body mass index greater than 35.0 kg/m².
* Known or severe lactose intolerance or milk protein allergy.
Primary outcome measure(s)
Change in Gastrointestinal Function Assessed by the PROMIS Gastrointestinal Combined Short Form — Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20 Gastrointestinal function will be assessed using the PROMIS Gastrointestinal Combined Short Form (PROMIS-GI-SF), a self-administered questionnaire assessing dimensions of gastrointestinal status and function. The primary endpoint is the change in gastrointestinal function from baseline to the end of the 16-week supplementation period.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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