An Exploratory Investigation of a Supplement to Promote Gut Health

ARMRA

Status: Completed

Conditions: Exercise Performance; Gastrointestinal Symptoms

Treatments: Drug: ARMRA™ Bovine Colostrum

Study type: Interventional

Funder types: Industry

Identifiers

NCT05831527

20255

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Gut Health Group

Experimental group

Description:

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.

Treatment:

Drug: ARMRA™ Bovine Colostrum

Exercise Performance Group

Experimental group

Description:

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.

Treatment:

Drug: ARMRA™ Bovine Colostrum