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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05887791
• Other study ID #: BTS1984/23
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: April 23, 2024

Study information

• Verified date: June 2023
• Source: Rousselot BVBA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: April 23, 2024
• Est. primary completion date: December 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Prediabetic State

Intervention

Dietary Supplement:
• Collagen hydrolysate
Single dose

Other:
• Placebo
Single dose

Locations

Country	Name	City	State
Germany	BioTeSys GmbH	Esslingen

Sponsors (2)

Lead Sponsor	Collaborator
Rousselot BVBA	BioTeSys GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gastrointestinal hormones	Peptid YY (PYY), Ghrelin, Cholecystokinin (CCK), Leptin	0-120 minutes postprandially
Other	Amino acids	Concentration-time curve of amino acids in plasma together with small molecular weight peptides	0-240 minutes postprandially
Primary	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	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
Secondary	Glucose Cmax	Maximum blood glucose concentration (Cmax)	0-180 minutes postprandially
Secondary	Delta Cmax	Maximum increase of blood glucose concentration	0-180 minutes postprandially
Secondary	Tmax	Time to reach maximum blood glucose concentration (Tmax)	0-180 minutes postprandially
Secondary	T baseline	First time to reach baseline again after increase or decrease in blood glucose	0-240 minutes postprandially
Secondary	Matsuda-Index	Determination of Insulin sensitivity	0-120 minutes postprandially
Secondary	Glucose dip	maximum dip below baseline and time point of glucose dip	0-240 minutes postprandially
Secondary	Insulin iAUC	Area under the curve calculated as the incremental area under the insulin curve	up to 0-240 minutes postprandially
Secondary	GLP-1	Incretin response (Glucagon-like Peptide-1)	0-120 minutes postprandially
Secondary	Satiety assessment	Visual analog scale (VAS) Scale (0: not at all 100: extremely)	0-240 minutes postprandially