Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile, Gastric Emptying and GLP-1 Release in Normoglycemic and Prediabetic Subjects

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

Aim of the study is to investigate the postprandial response on blood glucose, insulin, C-peptide, incretin response and gastric emptying after intake of collagen hydrolysate compared to placebo in normoglycemic and in prediabetic participants. This will be investigated in a cross-over randomized double-blind placebo controlled study design.

In an exploratory part II, timing of intake of collagen hydrolysate in relation to the mixed meal will be investigated in a subgroup of 50% of the participants.

Study Overview

• Status: Completed
• Conditions: Prediabetes; Normoglycemic
• Intervention / Treatment: Other: Placebo; Dietary supplement: Collagen hydrolyzed peptides

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Esslingen am Neckar, Germany, 73728
    • BioTeSys GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Flavoured water	Other: Placebo; Single dose
Active Comparator: Collagen hydrolysate; 30 min prior to the mixed meal test	Dietary supplement: Collagen hydrolyzed peptides; Dissolved in flavoured water, single dose, 10 g
Other: Collagen hydrolysate II; together with the mixed meal test	Dietary supplement: Collagen hydrolyzed peptides; Dissolved in flavoured water, single dose, 10 g

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose iAUC	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)	0-180 minutes postprandially

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose Cmax	Maximum blood glucose concentration (Cmax)	0-180 minutes postprandially
Delta Cmax	Maximum increase of blood glucose concentration	0-180 minutes postprandially
Tmax	Time to reach maximum blood glucose concentration (Tmax)	0-180 minutes postprandially
Matsuda-Index	Determination of Insulin sensitivity	0-120 minutes postprandially
Satiety assessment	Visual analog scale (VAS) Scale (0: not at all 100: extremely)	0-240 minutes postprandially
Fasting glucose	Fasting glucose	-30 minutes and 0 minutes prior mixed meal
Glucose	Blood glucose concentration after mixed meal	120 minutes
Fasting insulin	Fasting insulin	-30 minutes and 0 minutes prior to mixed meal
Insulin iAUC	Area under the curve calculated as the incremental area under the insulin curve	0-180 minutes postprandially
Fasting C-peptide	Fasting C-peptide	-30 minutes and 0 minutes prior mixed meal
C-peptide iAUC	Area under the curve calculated as the incremental area under the C-peptide curve	0-180 minutes postprandially
GLP-1 iAUC	Incretin response (Glucagon-like Peptide-1)	0-120 minutes postprandially
Fasting GLP-1	Fasting GLP-1	-30 minutes and 0 minutes prior mixed meal
Gastric emptying	Time for gastric emptying	0-6 hours postprandially

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal hormones	Glucose-dependent insulinotropic polypeptide (GIP)	0-120 minutes postprandially

Collaborators and Investigators

• Sponsor: Rousselot BVBA

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2025
• Primary Completion (Actual): September 8, 2025
• Study Completion (Actual): September 8, 2025

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): January 23, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: postprandial glucose; insulin response; glucose spikes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Prediabetic State
• Other Study ID Numbers: BTS2127/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No