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

NCT05391854 | Completed

• 1 other identifier: BTS1777/21
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetic State

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Glucose-iAUC(0-180min)

  Day 1; Day 85

• Cmax

  Day 1; Day 85

• Delta Cmax

  Day 1; Day 85

• Tmax

  Day 1; Day 85

• Tbaseline

  Day 1; Day 85

Study Arms (2)

Pep2dia

ACTIVE COMPARATOR

Dietary Supplement: Pep2dia

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Pep2dia DIETARY_SUPPLEMENT

700 mg Pep2Dia® 15 min prior to breakfast and 700 mg Pep2Dia® 15 min prior to dinner

Pep2dia

Placebo DIETARY_SUPPLEMENT

700 mg placebo 15 min prior to breakfast and 700 mg placebo 15 min prior to dinner

Placebo

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ingredia S.A.: lead
• BioTeSys GmbH: collaborator

Study Sites (1)

Biotesys

Esslingen am Neckar, Germany

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 26, 2022
• Study Start: June 21, 2022
• Primary Completion: May 5, 2023
• Study Completion: June 20, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

DE (1)