Colostrum and Gut Health

This randomized, double-blind, placebo-controlled, fully decentralized study will evaluate the effects of two daily doses of bovine colostrum compared with placebo on gastrointestinal health and related health outcomes in adults. Aadults aged 30 to 60 years will be enrolled and randomized in a 1:1:1 ratio to one of three study groups: one of two bovine colostrum doses or a matched placebo. The study is designed to obtain approximately 105 participants who complete the protocol. The study will be conducted entirely remotely, with no required in-person study visits. Following electronic screening and informed consent, eligible participants will complete baseline assessments through the Alethios digital research platform. Participants will then consume their assigned study product once daily with food for 16 weeks. The supplementation period will be followed by a 4-week non-supplementation period to evaluate outcomes following discontinuation of the study product. Total participant involvement is expected to be approximately 20 to 21 weeks. The primary objective is to evaluate changes in participant-reported gastrointestinal function during the 16-week supplementation period. Gastrointestinal function will be assessed using the PROMIS Gastrointestinal (GI) Combined Short Form, with the primary endpoint defined as the change from baseline to Week 16. Secondary outcomes will evaluate digestive comfort and gut health, perceived immune system strength and resilience, energy levels, sleep quality, metabolic health, gut microbiome status and function, and hair and skin health. Exploratory outcomes will include physical activity and heart rate variability derived from compatible wearable devices or connected health-data sources. Participant-reported assessments will be completed at scheduled intervals throughout the study, including baseline and Weeks 2, 4, 8, 12, 16, and/or 20, depending on the specific outcome. Digestive comfort/gut health and immune resilience assessments will continue through the 4-week post-supplementation period to characterize changes following discontinuation of the study product. Participants will also complete at-home biospecimen collections. Dried blood spot samples will be collected to assess metabolic health, including high-sensitivity C-reactive protein (hsCRP), and stool samples will be collected for assessment of gut microbiome status and function. These biospecimens will be collected at baseline and Week 16 and returned to designated analytical laboratories using provided collection and shipping materials. Participants will additionally provide standardized photographs for assessment of hair and skin health. Study product adherence will be monitored electronically through the study platform. Participants will record study product intake during the supplementation period and will be able to report adverse events or other health concerns throughout the study. Where available, compatible wearable devices or connected Apple Health/Google Fit data sources will be used to passively collect physical activity and heart rate variability data. The primary analysis will compare longitudinal changes in gastrointestinal function among the three randomized groups. A linear mixed-effects model will be used with supplementation group and time as fixed effects and participant as a random effect. Secondary and exploratory outcomes will be analyzed using statistical methods appropriate to the distribution and longitudinal structure of each outcome. The study is intended to characterize the effects of daily bovine colostrum supplementation on gastrointestinal function and related consumer health outcomes and to explore whether changes in gastrointestinal health are accompanied by changes in digestive comfort, immune resilience, energy, sleep, metabolic markers, gut microbiome characteristics, hair and skin health, physical activity, and heart rate variability.