Assessing collagen's effect on gastrointestinal discomfort in healthy adults

A Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Effect of Collagen Peptide on Perceived Gastrointestinal Discomfort in Healthy Adult Participants With Presence of Gastrointestinal Symptoms

This study is testing whether collagen supplements can help healthy adults with stomach discomfort feel better compared to a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 116 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Rousselot BVBA (Industry-sponsored)
• Locations: 1 site (Guelph, Ontario)
• Trial ID: NCT06937801 on ClinicalTrials.gov

What this trial studies

This interventional trial will enroll healthy adults experiencing gastrointestinal symptoms to evaluate the efficacy of collagen peptides compared to a placebo. It is designed as a double-blind, placebo-controlled study, focusing on various outcomes including gut microbiota composition, gut permeability, mood, anxiety, perceived stress, quality of life, and cognitive function. Participants will be required to maintain consistent dietary habits and lifestyle throughout the study period.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 64 with a BMI between 18.0 to 34.9 who experience mild to moderate gastrointestinal symptoms.

Not a fit: Patients with chronic illnesses or recent infections that could affect gastrointestinal function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new dietary intervention for alleviating gastrointestinal discomfort in healthy individuals.

How similar studies have performed: While the specific use of collagen peptides for gastrointestinal symptoms is less common, similar studies on dietary interventions have shown promising results.

Eligibility criteria

Inclusion Criteria:

1. Healthy adults from 18 to 64 years of age (inclusive).
2. Have a BMI between 18.0 to 34.9 kg/m2 (inclusive).
3. In good general health as determined by the investigator.
4. Are able to consume an animal-sourced powder product when mixed with water and taken orally.
5. Have a presence of GI symptoms as confirmed by a GSRS average score between 2 and 5 (inclusive).
6. Have maintained consistent dietary habits, including medication and supplement intake, and lifestyle for the last 3 months before screening and agree to maintain them throughout the study.
7. Agree to avoid anal penetration for 72 h prior to each fecal sample collection.
8. Agree to follow the restrictions on concomitant treatments, and lifestyle.
9. Agree to use acceptable contraceptive methods.
10. Willing and able to give voluntary consent, able to understand and read the questionnaires, carry out all study-related procedures and agree to the requirements of this study.

Exclusion Criteria:

1. Individuals who are lactating, pregnant or planning to become pregnant during the study.
2. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
3. Current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (WHO).
4. Recent history of an episode of acute GI illness such as nausea, vomiting, or diarrhea.
5. Have Type I diabetes, uncontrolled Type II diabetes, uncontrolled high blood pressure (≥140 systolic or ≥90 diastolic mmHg), or uncontrolled thyroid disease ("uncontrolled" defined as being unmedicated, have an unstable use of medication within 3 months prior to screening, or have a stable use of medication for 3 months but still have uncontrolled conditions).
6. Have a current diagnosis or history of irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), functional constipation or diarrhea (defined by the ROME IV diagnostic criteria), celiac disease, malabsorption, gastroparesis, endometriosis or eating disorder.
7. Have a chronic inflammatory condition/disease (e.g., rheumatoid arthritis, ulcerative colitis, lupus).
8. Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).
9. Have a history of heart/cardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or immunocompromised (i.e., HIV/AIDS).
10. Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer), unless recovery occurred more than 5 years before the screening visit.
11. Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, generalized anxiety disorder, bipolar disorder, schizophrenia, etc.).
12. Reports a clinically significant illness during the 28 days before the first dose of study product.
13. Major surgery in 3 months prior to screening or planned major surgery during the study.
14. Have a history of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program) or use that in the opinion of the investigator may be of a concern for the study.
15. Current enrollment or past participation in another study with any product(s) with at least one active ingredient within 28 days before first dose of study product or longer.
16. Living in the same household as another currently/previously enrolled participant in the present study.
17. Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.

Where this trial is running

Guelph, Ontario

• Nutrasource Site (Apex Trials) — Guelph, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Jevaneeh Rubio

Conditions Gastrointestinal Disorders; Gastrointestinal discomfort; gastrointestinal symptoms