Health TrialsbyHealthPanel

Colostrum and Gut Health

ConditionGastrointestinal Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
SponsorBovita Labs, LLC

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

140 Participants
are divided into 3 treatment groups
Group A: Lower Dose Bovine ColostrumExperimental treatment 1 intervention
Group B: Higher-Dose Bovine ColostrumExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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.
2

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bovita Labs, LLC

Lead sponsor

Source ClinicalTrials.gov

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