Effects of collagen hydrolysate on blood sugar levels and digestion
Clinical Study to Evaluate the Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile, Gastric Emptying and GLP-1 Release in Normoglycemic and Prediabetic Subjects: Randomized, Double-blind, Placebo-controlled, Cross-over Design
NA · Rousselot BVBA · NCT06789263
This study tests whether taking collagen hydrolysate can help people with prediabetes and those with normal blood sugar levels manage their blood sugar and digestion better after meals.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Rousselot BVBA (industry) |
| Locations | 1 site (Esslingen) |
| Trial ID | NCT06789263 on ClinicalTrials.gov |
What this trial studies
This study investigates how collagen hydrolysate affects blood glucose levels, insulin response, and gastric emptying in individuals with prediabetes and those who are normoglycemic. Participants will receive either collagen hydrolysate or a placebo in a randomized, double-blind, crossover design. The study will also explore the timing of collagen intake in relation to meals for a subset of participants. The goal is to understand the potential benefits of collagen hydrolysate on postprandial glucose management.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-70 with prediabetes or healthy individuals with normal blood glucose levels.
Not a fit: Patients with diagnosed Type 2 Diabetes or those on medications affecting glucose tolerance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary approach to managing blood sugar levels in prediabetic and normoglycemic individuals.
How similar studies have performed: While there is limited research specifically on collagen hydrolysate for glucose management, similar studies on dietary interventions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Prediabetic subjects: Male and female subjects with prediabetic HbA1c values between 5.7% and 6.4% and/or fasting glucose ≥ 100 mg/dL and ≤ 125 mg/dL (in venous plasma) (twice confirmed at two independent days if HbA1c is \< 5.7%) or Healthy normoglycemic subjects: fasting glucose \<100 mg/dL and HbA1c is \< 5.7% * Age: 18-70 years * Body mass index 19-35 kg/m2 * Current Non-smoker * Signed informed consent form * No changes in food habits or physical activity 3 months prior to screening and during the study * If applicable, stable intake of chronic medication of at least 4 weeks Exclusion Criteria: * Subjects with diagnosed Type 2 Diabetes mellitus with medical treatment * Presence of disease or drug(s) influencing digestion (incl. recent intake of antibiotics) and absorption of nutrients * Intake of medications known to affect glucose tolerance, e.g., diabetic medication, SGLT-2 inhibitors, GLP-1 receptor agonists, steroids, protease inhibitors or antipsychotics * Chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mg as standard prophylactic treatment allowed when dose is stable 1 month prior to screening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowed e.g. for hypertension treatment when dose is stable 1 month prior to screening), which in the Investigator's opinion would impact patient safety * Severe liver or renal disease or laboratory evidence of hepatic dysfunction (i.e. alkaline phosphatase, ALT, AST \>3 x ULN) * Known inflammatory or malignant gastrointestinal diseases (i.e. colitis ulcerosa, Morbus Crohn, celiac disease, malignant diseases e.g. colon-cancer, rectum cancer, pancreatitis) * Subjects who use an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump. * Planned MRI during or 4 weeks after the study. * Subjects overweighed with abdominal diameter \>140 cm * Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs * Major medical or surgical event requiring hospitalization within the previous 3 months * Intake of food supplements known to affect glucose tolerance, e.g., cinnamon capsules, conjugated linoleic acids * Drug-, alcohol- and medication abuses * Pregnant or breast-feeding women * Weight loss intervention or recent body weight change \>5 kg during the last 3 months * Blood donation within 4 weeks prior to Screeningor plan to donate blood during the study * Anticipating any planned changes in lifestyle for the duration of the study * Participation in another clinical intervention study within the last 4 weeks and concurrent participation in another intervention clinical study * Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
Where this trial is running
Esslingen
- BioTeSys GmbH — Esslingen, Germany (RECRUITING)
Study contacts
- Study coordinator: Nicolina Virgilio, PhD
- Email: nicoletta.virgilio@rousselot.com
- Phone: +32 9 255 1808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prediabetes, Normoglycemic, glucose spikes, postprandial glucose, insulin response