An Exploratory Investigation of a Supplement to Promote Gut Health

NCT05831527 | Completed

• 1 other identifier: 20255
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Symptoms; Exercise Performance

Outcome Measures

Primary Outcomes (2)

• 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").

  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.

  12 weeks

Secondary Outcomes (2)

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

  12 weeks

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

  12 weeks

Study Arms (2)

Gut Health Group

EXPERIMENTAL

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

Exercise Performance Group

EXPERIMENTAL

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

Interventions

ARMRA™ Bovine Colostrum 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; Gut Health Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Armra: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 09404, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multiarm study, both arms receiving the same intervention drug.

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 26, 2023
• Study Start: September 25, 2022
• Primary Completion: March 24, 2023
• Study Completion: March 24, 2023
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

US (1)