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

NCT06789263 | Completed

• 1 other identifier: BTS2127/24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prediabetes; Normoglycemic

Keywords

glucose spikes; postprandial glucose; insulin response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Glucose Cmax

  0-180 minutes postprandially

• Delta Cmax

  0-180 minutes postprandially

• Tmax

  0-180 minutes postprandially

• Fasting glucose

  -30 minutes and 0 minutes prior mixed meal

• Glucose

  120 minutes

Other Outcomes (1)

• Gastrointestinal hormones

  0-120 minutes postprandially

Study Arms (3)

Collagen hydrolysate

ACTIVE COMPARATOR

30 min prior to the mixed meal test

Dietary Supplement: Collagen hydrolyzed peptides

Placebo

PLACEBO COMPARATOR

Flavoured water

Other: Placebo

Collagen hydrolysate II

OTHER

together with the mixed meal test

Dietary Supplement: Collagen hydrolyzed peptides

Interventions

Placebo OTHER

Single dose

Placebo

Collagen hydrolyzed peptides DIETARY_SUPPLEMENT

Dissolved in flavoured water, single dose, 10 g

Collagen hydrolysate; Collagen hydrolysate II

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rousselot BVBA: lead

Study Sites (1)

BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 23, 2025
• Study Start: January 29, 2025
• Primary Completion: September 8, 2025
• Study Completion: September 8, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)