An Exploratory Investigation of a Supplement to Promote Gut Health

Exercise Performance Clinical Trial

Official title:

An Exploratory Investigation of a Supplement to Promote Gut Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05831527
• Other study ID #: 20255
• Status: Completed
• Phase: N/A
• Start date: September 25, 2022
• Est. completion date: March 24, 2023

Study information

• Verified date: April 2023
• Source: Armra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 24, 2023
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise Performance
• Gastrointestinal Symptoms

Intervention

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.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Armra	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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").	12 weeks
Secondary	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").	12 weeks