An Exploratory Investigation of a Supplement to Promote Gut Health

April 25, 2023 updated by: Armra
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 09404
        • Citruslabs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Experimental: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in overall well-being [Time Frame: Baseline to Week 12]
Time Frame: 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").
12 weeks
Change in hs-CRP [Time Frame: Baseline to Week 12]
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-reported gastrointestinal outcomes, such as bloating, heartburn, irregular bowel movements, and gas [Time Frame: Baseline to Week 12]
Time Frame: 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").
12 weeks
Change in recovery and fitness levels [Time Frame: Baseline to Week 12]
Time Frame: 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").
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armra

Collaborators

Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2022

Primary Completion (Actual)

March 24, 2023

Study Completion (Actual)

March 24, 2023

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 20255

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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