An Exploratory Investigation of a Supplement to Promote Gut Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-25

Study Completion Date

2023-03-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastrointestinal Symptoms Exercise Performance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Multiarm study, both arms receiving the same intervention drug.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Gut Health Group

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.

Group Type EXPERIMENTAL

ARMRA™ Bovine Colostrum

Intervention Type DRUG

Participants have the option to choose between unflavoured ARMRA™ Bovine Colostrum or blood orange flavoured ARMRA™ Bovine Colostrum.

Participants took 2 sachets (1g each) of the product mixed with a cold drink daily for 12 weeks.

Exercise Performance Group

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.

Group Type EXPERIMENTAL

ARMRA™ Bovine Colostrum

Intervention Type DRUG

Participants have the option to choose between unflavoured ARMRA™ Bovine Colostrum or blood orange flavoured ARMRA™ Bovine Colostrum.

Participants took 2 sachets (1g each) of the product mixed with a cold drink daily for 12 weeks.

Interventions

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ARMRA™ Bovine Colostrum

Participants have the option to choose between unflavoured ARMRA™ Bovine Colostrum or blood orange flavoured ARMRA™ Bovine Colostrum.

Participants took 2 sachets (1g each) of the product mixed with a cold drink daily for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes