An interventional study of Bovine Colostrum - Lower Dose and Bovine Colostrum - Higher Dose in Gastrointestinal Health, sponsored by Bovita Labs, LLC. Not yet recruiting at 1 site in United States. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Bovita Labs, LLC · Not applicable, Interventional, and Other
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.
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.
This is the only study on the registry with Bovita Labs, LLC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 - Lower 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: Bovine Colostrum - Higher Dose
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.
Dietary Supplement: Placebo
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.
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.
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.
Change in Gastrointestinal Function Assessed by the PROMIS Gastrointestinal Combined Short Form
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.
Time frame: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20
Change in Digestive Comfort and Gut Health
Participants will rate their digestive comfort and gut health by answering the question, "Overall, how would you rate for digestive health and gut comfort today?" Answers are provided using a visual analog scale ranging from 0 (Very Poor) to 100 (Excellent).
Time frame: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20
Change in Perceived Immune System Strength and Resilience
Participants will rate their immune strength and resilience by answering the question, "How would you rate the overall strength and resilience of your immune system over the past 7 days?" Answers are provided using a visual analog scale ranging from 0 (Very Poor) to 100 (Excellent).
Time frame: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20
Change in Participant-Reported Energy Levels
Participants will rate their energy levels by answering the question, "In the past 7 days, how would you rate your overall energy levels throughout the day?" Answers are provided on a Likert scale ranging from 1 (Very low energy) to 7 (Very high energy).
Time frame: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16
Change in Participant-Reported Sleep Quality
Participants will rate their sleep quality by answering the question, "In the past 7 days, how would you rate the quality of your sleep overall?" Answers are provided on a Likert scale ranging from 1 (Very poor sleep) to 7 (Excellent sleep).
Time frame: Week 0, Week 2, Week 4, Week 8, Week 12, Week 16
Change in total cholesterol
At-home dried blood spot samples will be collected to evaluate concentrations of total cholesterol. Units of measure are in milligrams per deciliter.
Time frame: Week 0 and Week 16
Evaluation of baseline and change in microbial diversity
Participant-collected stool samples will be analyzed to evaluate changes in microbial diversity. Evaluations are made based on detected bacterial taxa and strains. An index (unitless) is provided.
Time frame: Week 0 and Week 16
Change in Hair Strength
Participants will rate their hair strength by answering the question, "My hair feels more nourished and less dry or brittle? Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Time frame: Week 0 and Week 16
Change in Skin Hydration
Participants will rate their skin hydration by answering the question, "My skin feels hydrated?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Time frame: Week 0 and Week 16
Change in HDL cholesterol
At-home dried blood spot samples will be collected to evaluate concentrations of high-density lipoprotein (HDL) cholesterol. Units of measure are in milligrams per deciliter.
Time frame: Week 0 and Week 16
Change in LDL cholesterol
At-home dried blood spot samples will be collected to evaluate concentrations of low-density lipoprotein (LDL) cholesterol. Units of measure are in milligrams per deciliter.
Time frame: Week 0 and Week 16
Change in high-sensitivity C-reactive protein
At-home dried blood spot samples will be collected to evaluate concentrations of high-sensitivity C-reactive protein (CRP). Units of measure are in milligrams per liter.
Time frame: Week 0 and Week 16
Change in hemoglobin A1c (HbA1c)
At-home dried blood spot samples will be collected to evaluate levels of hemoglobin A1c (HbA1c). Units of measure are in % of total hemoglobin.
Time frame: Week 0 and Week 16
Change in gamma-glutamyl transferase (GGT)
At-home dried blood spot samples will be collected to evaluate concentrations of gamma-glutamyl transferase (GGT). Units of measure are in units per liter.
Time frame: Week 0 and Week 16
Change in fasting glucose
At-home dried blood spot samples will be collected to evaluate fasting concentrations of glucose. Units of measure are in milligrams per deciliter.
Time frame: Week 0 and Week 16
Evaluation of baseline and change in microbial abundance
Participant-collected stool samples will be analyzed to evaluate changes in microbial abundance. Evaluations are made based on detected bacterial taxa and strains. A percentage or proportion of relative abundance of total bacterial sequences will be quantified.
Time frame: Week 0 and Week 16
Evaluation of baseline and change in microbial richness
Participant-collected stool samples will be analyzed to evaluate changes in microbial richness. Evaluations are made based on detected bacterial taxa and strains. An index (unitless) is provided.
Time frame: Week 0 and Week 16
Evaluation of baseline and change in microbial evenness
Participant-collected stool samples will be analyzed to evaluate changes in microbial evenness. Evaluations are made based on detected bacterial taxa and strains. An index (unitless) is provided.
Time frame: Week 0 and Week 16
Evaluation of baseline and change in the amount of short-chain fatty acid producers
Participant-collected stool samples will be analyzed to evaluate changes in bacterial taxa that are known fatty acid chain producers. General relative abunance (%) will be provided.
Time frame: Week 0 and Week 16
Change in the ratio of triglycerides to HDL cholesterol ratio
At-home dried blood spot samples will be collected to evaluate changs in the ratio of triglycerides to HDL choelsterol. This measurement is a unitless ratio.
Time frame: Week 0 and Week 16
Change in triglycerides
At-home dried blood spot samples will be collected to evaluate concentrations of triglycerides. Units of measure are in milligrams per deciliter.
Time frame: Week 0 and Week 16
Modified hair pull test
Participants will complete a modified hair pull test. The number of hair strands yielded from the hair pull test will be counted and used for assessment.
Time frame: Week 0 and Week 16
Change in Hair Quality
Participants will rate their hair quality by answering the question, "I have noticed an improvement in overall hair quality?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Time frame: Week 0 and Week 16
Change in Hair Health
Participants will rate their hair health by answering the question, "I have noticed an improvement in the appearance of hair health?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Time frame: Week 0 and Week 16
Change in Hair Texture
Participants will rate their hair texture by answering the question, "I have noticed an improvement in hair texture?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Time frame: Week 0 and Week 16
Change in Hair Volume
Participants will rate their hair volume by answering the question, "I have noticed an improvement in hair volume?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Time frame: Week 0 and Week 16
Change in Hair Shedding
Participants will rate their hair shedding by answering the question, "I have noticed an improvement in hair shedding?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Time frame: Week 0 and Week 16
Change in Clearness of Skin
Participants will rate their skin clearness by answering the question, "My skin appears clear?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Time frame: Week 0 and Week 16
Change in Overall Skin Health
Participants will rate their overall skin health by answering the question, "I have noticed an improvement in my overall skin health?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Time frame: Week 0 and Week 16
Change in Dry Skin
Participants will rate their overall skin dryness by answering the question, "I am experiencing dry skin?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Time frame: Week 0 and Week 16
Change in Happiness with Skin
Participants will rate their overall happiness with their skin by answering the question, "I am happy with my skin?" Answers are provided using a 5-point Likert style scale with 1=Strongly Disagree and 5=Strongly Agree.
Time frame: Week 0 and Week 16
Daily Step Count
Step count data will be passively collected, where available, from compatible wearable devices or connected Apple Health/Google Fit data sources.
Time frame: Baseline through Week 20.
Change in Wearable-Derived Heart Rate Variability
Heart rate variability will be passively collected from compatible wearable devices or connected health-data sources where available
Time frame: Baseline through Week 20
Plan to share: No — Individual participant data will not be made publicly available due to participant privacy considerations, the inclusion of multiple potentially sensitive data types, and sponsor data-governance requirements. Aggregate study results may be disseminated through scientific publication and other appropriate channels.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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