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Completed

NCT Number: NCT05831527

An Exploratory Investigation of a Supplement to Promote Gut Health

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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Key information

Conditions

Gastrointestinal Symptoms Exercise Performance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 09404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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").

  2. 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.

Secondary outcomes

  1. 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").

  2. 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").

Sponsors and collaborators

Lead sponsor

Armra

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 26, 2023
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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