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

Clinical Study to Assess the Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile in Prediabetic and Healthy Subjects: Randomized, Double-blind, Placebo-controlled, Cross-over Study With Different Dosages

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy; Prediabetic State
• Intervention / Treatment: Other: Placebo; Dietary supplement: Collagen hydrolysate

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Esslingen, Germany, 73728
    • BioTeSys GmbH

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Collagen hydrolysate dose 1; Source: porcine; standardized to 10 g provided as single dose. Orally applied in flavoured water.	Dietary supplement: Collagen hydrolysate; Single dose
Experimental: Collagen hydrolysate dose 2; Source: porcine; standardized to 5 g provided as single dose. Orally applied in flavoured water.	Dietary supplement: Collagen hydrolysate; Single dose
Placebo Comparator: Placebo; Flavoured water	Other: Placebo; Single dose

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal hormones	Peptid YY (PYY), Ghrelin, Cholecystokinin (CCK), Leptin	0-120 minutes postprandially
Amino acids	Concentration-time curve of amino acids in plasma together with small molecular weight peptides	0-240 minutes postprandially

Collaborators and Investigators

• Sponsor: Rousselot BVBA
• Collaborators: BioTeSys GmbH
• Investigators: Study Director: Nicoletta Virgilio, PhD, Rousselot BV

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Actual): December 23, 2023
• Study Completion (Estimated): April 23, 2024

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: collagen peptides; blood sugar modifying
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: BTS1984/23

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