An Exploratory Investigation of a Supplement to Promote Gut Health

Armra60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Gastrointestinal Symptoms Exercise Performance

Interventions

ARMRA™ Bovine ColostrumDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Citruslabs

Santa Monica, California, United States

Outcomes

Primary Outcomes

Change in overall well-being [Time Frame: Baseline to Week 12]

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").

Time frame: 12 weeks

Change in hs-CRP [Time Frame: Baseline to Week 12]

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.

Time frame: 12 weeks

Secondary Outcomes

Change in self-reported gastrointestinal outcomes, such as bloating, heartburn, irregular bowel movements, and gas [Time Frame: Baseline to Week 12]

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").

Time frame: 12 weeks

Change in recovery and fitness levels [Time Frame: Baseline to Week 12]

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").

Data from ClinicalTrials.gov

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