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

Not Applicable

Completed

• Conditions: Healthy; Prediabetic State
• Interventions: Dietary Supplement: Collagen hydrolysate; Other: Placebo

• Registration Number: NCT05887791
• Lead Sponsor: Rousselot BVBA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-05-24
• Status Verified: 2023-06
• Study First Posted: 2023-06-05
• Study Start: 2023-06-15
• Primary Completion: 2023-12-23
• Study Completion: 2024-04-01
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Collagen hydrolysate dose 1	Collagen hydrolysate	Source: porcine; standardized to 10 g provided as single dose. Orally applied in flavoured water.
Placebo	Placebo	Flavoured water
Collagen hydrolysate dose 2	Collagen hydrolysate	Source: porcine; standardized to 5 g provided as single dose. Orally applied in flavoured water.

Primary Outcome Measures

Name	Time	Method
Glucose iAUC	0-180 minutes postprandially	Area under the curve (AUC) calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration: Glucose-iAUC(0-180minutes)

Secondary Outcome Measures

Name	Time	Method
Glucose dip	0-240 minutes postprandially	maximum dip below baseline and time point of glucose dip
Satiety assessment	0-240 minutes postprandially	Visual analog scale (VAS) Scale (0: not at all 100: extremely)
Glucose Cmax	0-180 minutes postprandially	Maximum blood glucose concentration (Cmax)
Tmax	0-180 minutes postprandially	Time to reach maximum blood glucose concentration (Tmax)
Delta Cmax	0-180 minutes postprandially	Maximum increase of blood glucose concentration
T baseline	0-240 minutes postprandially	First time to reach baseline again after increase or decrease in blood glucose
Insulin iAUC	up to 0-240 minutes postprandially	Area under the curve calculated as the incremental area under the insulin curve
GLP-1	0-120 minutes postprandially	Incretin response (Glucagon-like Peptide-1)
Glucose iAUC	0-240 minutes postprandially	Area under the curve calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration: Glucose-iAUC(0-240minutes)
Matsuda-Index	0-120 minutes postprandially	Determination of Insulin sensitivity

Trial Locations

Locations (1)

BioTeSys GmbH; 🇩🇪 Esslingen, Germany