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

Clinical Study to Assess the Long-term Effect of Pep2Dia® on Glucose Homeostasis in Prediabetic Subjects: a 12-week Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel Study

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.

Study Overview

• Status: Completed
• Conditions: Prediabetic State
• Intervention / Treatment: Dietary supplement: Pep2dia; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Esslingen, Germany
    • Biotesys

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; 700 mg placebo 15 min prior to breakfast and 700 mg placebo 15 min prior to dinner
Active Comparator: Pep2dia	Dietary supplement: Pep2dia; 700 mg Pep2Dia® 15 min prior to breakfast and 700 mg Pep2Dia® 15 min prior to dinner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycated haemoglobin (HbA1c)	Change from baseline Glycated haemoglobin (HbA1c) at 3 months	Before treatment (baseline = day 0); at the end of the treatment (after 3 months = day 85)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ingredia S.A.
• Collaborators: BioTeSys GmbH

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Actual): May 5, 2023
• Study Completion (Actual): June 20, 2023

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: BTS1777/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No