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

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

Placebo

Collagen hydrolyzed peptides

Clinical Study ID

NCT06789263

BTS2127/24

Ages 18-70
All Genders
Accepts Healthy Volunteers

Study 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

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 Healthynormoglycemic 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 andduring the study
If applicable, stable intake of chronic medication of at least 4 weeks

Exclusion

Exclusion Criteria:

Subjects with diagnosed Type 2 Diabetes mellitus with medical treatment
Presence of disease or drug(s) influencing digestion (incl. recent intake ofantibiotics) 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 orantipsychotics
Chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mgas standard prophylactic treatment allowed when dose is stable 1 month prior toscreening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowede.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 asa 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, physicalexamination, clinical laboratory and/or vital signs
Major medical or surgical event requiring hospitalization within the previous 3months
Intake of food supplements known to affect glucose tolerance, e.g., cinnamoncapsules, 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 thestudy
Anticipating any planned changes in lifestyle for the duration of the study
Participation in another clinical intervention study within the last 4 weeks andconcurrent participation in another intervention clinical study
Subjects considered inappropriate for the study by investigators, including subjectswho are unable or unwilling to show compliance with the protocol

Study Design