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

Not Applicable

Completed

• Conditions: Prediabetic State
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Pep2dia

• Registration Number: NCT05391854
• Lead Sponsor: Ingredia S.A.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-26
• Study Start: 2022-06-21
• Primary Completion: 2023-05-05
• Status Verified: 2023-06
• Study Completion: 2023-06-20
• Last Update Submitted: 2023-06-26
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Pep2dia	Pep2dia	-

Primary Outcome Measures

Name	Time	Method
Glycated haemoglobin (HbA1c)	Before treatment (baseline = day 0); at the end of the treatment (after 3 months = day 85)	Change from baseline Glycated haemoglobin (HbA1c) at 3 months

Secondary Outcome Measures

Name	Time	Method
Cmax	Day 1; Day 85	Maximum blood glucose concentration
hsCRP	Day 1; Day 85
GLP-1	Day 1; Day 85
SF-12 (Short-fom 12)	Day 1; Day 85	Score from 12 to 60. Higher score mean a better outcome.
Glucose-iAUC(0-180min)	Day 1; Day 85	Area under the curve calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration
Tbaseline	Day 1; Day 85	First time to reach baseline again after increase or decrease in blood glucose
Delta Cmax	Day 1; Day 85	Maximum increase of glucose (Cmax minus baseline value)
Tmax	Day 1; Day 85	Time to reach maximum blood glucose concentration
ISI 0-120min	Day 1; Day 85
Body composition measurement	Day 1; Day 85	Evaluation of the fat mass/lean mass ratio by bioelectrical impedance analysis

Trial Locations

Locations (1)

Biotesys; 🇩🇪 Esslingen, Germany