An Exploratory Investigation of a Supplement to Promote Gut Health

Not Applicable

Completed

• Conditions: Gastrointestinal Symptoms; Exercise Performance
• Interventions: Drug: ARMRA™ Bovine Colostrum

• Registration Number: NCT05831527
• Lead Sponsor: Armra

Brief Summary

Bovine colostrum is a dairy food and the first milk produced by the mother cow. Abundant research exists revealing the valuable health benefits it confers due to its unique nutritional properties., including benefits to gastrointestinal health, fitness, and overall well-being.This study aims to test a specific food-grade supplement, ARMRA Colostrum Immune Revival, over a 12-week trial to better understand the well-being, fitness, and gut benefits. This trial will use two groups, one that suffers from gastrointestinal complaints frequently and another that exercises at least three days a week.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-25
• Primary Completion: 2023-03-24
• Study Completion: 2023-03-24
• Status Verified: 2023-04
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-25
• Last Update Submitted: 2023-04-25
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Male or Female between 18-65 years of age.
• Self-reported digestive issues (abdominal pain, gas production, bloating after meals, or heartburn after meals) (GUT HEALTH GROUP ONLY)
• Must be physically active three or more days a week and willing to maintain their current activity level (PERFORMANCE GROUP ONLY)
• Must be willing to refrain from lifestyle changes affecting their gastrointestinal tract.
• Must be in good health with no significant chronic conditions.
• Following a stable, consistent diet regimen.
• Have a reliable way to measure their weight.

Exclusion Criteria

• Females who are pregnant or breastfeeding
• Suffers from pre-existing conditions that would prevent them from adhering to the protocol.
• Has a lactose allergy or intolerance.
• Serious food allergies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gut Health Group	ARMRA™ Bovine Colostrum	Subjects with self-reported digestive issues (abdominal pain, gas production, bloating after meals, or heartburn after meals) Dose: two sachets daily (1g each) mixed with a cold drink, for 12 weeks.
Exercise Performance Group	ARMRA™ Bovine Colostrum	Subjects that are physically active three or more days a week. Dose: two sachets daily (1g each) mixed with a cold drink, for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in overall well-being [Time Frame: Baseline to Week 12]	12 weeks	Well-being will be measured via study-specific surveys. Data was collected using a textual 5 or 6-point Likert scale for each question, such as "Not noticeable" to "severe." Symptom-related questions were conducted at baseline and each check-in. The textual Likert data was transformed into numerical values of 1-6, with 1 representing the least favorable/worse outcome ("severe" response to the question, "how severe would you rate your stress"), and 6 representing the most beneficial response (i.e., "no symptoms" to the question, "how severe would you rate your stress").
Change in hs-CRP [Time Frame: Baseline to Week 12]	12 weeks	Biomarker assessment will be completed to assess changes in hs-CRP. Participants will complete a finger-prick dried blood spot test, at Baseline and Week 12.

Secondary Outcome Measures

Name	Time	Method
Change in self-reported gastrointestinal outcomes, such as bloating, heartburn, irregular bowel movements, and gas [Time Frame: Baseline to Week 12]	12 weeks	In the Gut Health Group only: Assessed via self-reported gastrointestinal outcomes such as bloating, heartburn, irregular bowel movements, and gas. Data was collected using a textual 5 or 6-point Likert scale for each question, such as "Not noticeable" to "severe." Symptom-related questions were conducted at baseline and each check-in. The textual Likert data was transformed into numerical values of 1-6, with 1 representing the least favorable/worse outcome ("severe" response to the question, "how severe would you rate your stress"), and 6 representing the most beneficial response (i.e., "no symptoms" to the question, "how severe would you rate your stress").
Change in recovery and fitness levels [Time Frame: Baseline to Week 12]	12 weeks	In the Exercise Performance Group only: Assessed via self-reported questionnaires. Data was collected using a textual 5 or 6-point Likert scale for each question, such as "Not noticeable" to "severe." Symptom-related questions were conducted at baseline and each check-in. The textual Likert data was transformed into numerical values of 1-6, with 1 representing the least favorable/worse outcome ("severe" response to the question, "how severe would you rate your stress"), and 6 representing the most beneficial response (i.e., "no symptoms" to the question, "how severe would you rate your stress").

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States