Clinical Study to Assess the Long-term Effect of Pep2Dia® on Glucose Homeostasis in Prediabetic Subjects

Ingredia

Status

Completed

Conditions

Prediabetic State

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Pep2dia

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05391854

BTS1777/21

Details and patient eligibility

About

The goal is to assess the long-term effect of Pep2Dia® compared to placebo intake on blood glucose homeostasis. Respective improvements will be assessed by changes in glycated haemoglobin (HbA1c) before and after the 12-weeks intervention.

Enrollment

128 patients

Sex

All

Ages

25 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male and female subjects (minimum one third of each gender) with prediabetic HbA1c values between 5.7% and 6.4% and/or fasting glucose ≥ 5.6 mmol/L (≥ 100 mg/dL) and < 7.0 mmol/L (< 125 mg/dL) (in venous plasma) (twice confirmed at two independent days if HbA1c is < 5.7%)
Age: 25-70 years
Body mass index 19-35 kg/m2
Current Non-smoker
Availability and presence in the study units for approx. 3.5 hours/ week for 2 times.
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 with medical treatment
Presence of disease or drug(s) influencing digestion 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)
Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks
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
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, omega-3 fatty acids
Intake of antibiotics within 4 weeks before the test days
Known alcohol abuse or drug abuse
Pregnant or breast-feeding women
Weight loss intervention or recent body weight change >5 kg during last 3 months
Known or suspected allergy to any component of the investigational product(s) (e.g. milk protein)
Blood donation within 4 weeks prior to Visit 1 or 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
Subject unable to co-operate adequately