Clinical trial NCT06789263: Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile, Gastric Emptying and GLP-1 Release in Normoglycemic and Prediabetic Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prediabetes
Normoglycemic
Keywords: glucose spikes
postprandial glucose
insulin response
Lead sponsor: Rousselot BVBA
Sponsor class: INDUSTRY
First posted: 2025-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Glucose iAUC
timeFrame: 0-180 minutes postprandially
Secondary outcomes:
measure: Glucose Cmax
timeFrame: 0-180 minutes postprandially
measure: Delta Cmax
timeFrame: 0-180 minutes postprandially
measure: Tmax
timeFrame: 0-180 minutes postprandially
measure: Fasting glucose
timeFrame: -30 minutes and 0 minutes prior mixed meal
measure: Glucose
timeFrame: 120 minutes
measure: Fasting insulin
timeFrame: -30 minutes and 0 minutes prior to mixed meal
measure: Insulin iAUC
timeFrame: 0-180 minutes postprandially
measure: Fasting C-peptide
timeFrame: -30 minutes and 0 minutes prior mixed meal
measure: C-peptide iAUC
timeFrame: 0-180 minutes postprandially
measure: GLP-1 iAUC
timeFrame: 0-120 minutes postprandially
measure: Fasting GLP-1
timeFrame: -30 minutes and 0 minutes prior mixed meal
measure: Matsuda-Index
timeFrame: 0-120 minutes postprandially
measure: Gastric emptying
timeFrame: 0-6 hours postprandially
measure: Satiety assessment
timeFrame: 0-240 minutes postprandially
Other outcomes:
measure: Gastrointestinal hormones
timeFrame: 0-120 minutes postprandially
Locations:
city: Esslingen
country: Germany
facility: BioTeSys GmbH
Study officials:
References: