Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile in Prediabetic and Healthy Subjects

Rousselot

Status: Completed

Conditions: Prediabetic State; Healthy

Treatments: Dietary Supplement: Collagen hydrolysate; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05887791

BTS1984/23

Details and patient eligibility

About

To investigate the effect of two different dosages collagen hydrolysate (CH) on postprandial blood glucose and insulin profile in prediabetic and normo-glycaemic subjects.This will be investigated in a cross-over randomized double-blind placebo controlled study design.

Enrollment: 15 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Main 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 normo-glycaemic 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

Main 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)
• Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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15 participants in 3 patient groups, including a placebo group

Collagen hydrolysate dose 1

Experimental group

Description:

Source: porcine; standardized to 10 g provided as single dose. Orally applied in flavoured water.

Treatment:

Dietary Supplement: Collagen hydrolysate

Collagen hydrolysate dose 2

Experimental group

Description:

Source: porcine; standardized to 5 g provided as single dose. Orally applied in flavoured water.

Treatment:

Dietary Supplement: Collagen hydrolysate

Placebo

Placebo Comparator group

Description:

Flavoured water

Treatment:

Other: Placebo