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

COMPLETEDNA

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

NCT05391854•Ingredia S.A.

View on ClinicalTrials.gov

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.

Eligibility

Age

25 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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
+9 more criteria

Locations (1)

Biotesys

Esslingen am Neckar, Germany

Key Dates

Start Date

June 21, 2022

Primary Completion Date

May 5, 2023

Completion Date

June 20, 2023

Last Updated

June 28, 2023

Enrollment

128

ACTUAL participants

Conditions

Prediabetic State

Interventions

Pep2dia

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

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Prediabetic StateCardiovascular Diseases+2 more

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Role of Aging and Individual Variation in Exercise Training Responsiveness

PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes

Effect of Zinc on Glucose Homeostasis

Exercise Training and Fat Metabolism in Postmenopausal Women

Efficacy of High-intensity Exercise in Women With Prediabetes

Effect of Insulin Lowering on Lipogenesis