Investigation of Milk Peptides (Pep2Dia®) on Postprandial Blood Glucose Profile in Prediabetic Subjects

NCT04375449 | Completed DMC

• 1 other identifier: BTS1472/20
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal is to investigate the 180 min postprandial response on blood glucose and insulin levels after intake of Pep2Dia® in two different dosages compared to placebo in the context of a meal challenge test, providing 75 g of carbohydrates. Pep2Dia® will be administered 15 min prior to a standardized challenge meal.

Conditions

Prediabetic State

Outcome Measures

Primary Outcomes (1)

• 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 (according to ISO 26642:2010(E)

  Day 1, Day 15, Day 29

Secondary Outcomes (8)

• Cmax

  Day 1, Day 15, Day 29

• Max_increase

  Day 1, Day 15, Day 29

• Tmax

  Day 1, Day 15, Day 29

• Tbaseline

  Day 1, Day 15, Day 29

• AUC(0-180min)

  Day 1, Day 15, Day 29

Study Arms (3)

Pep2dia- dosage 1

ACTIVE COMPARATOR

700mg of whey protein hydrolysates single dose

Dietary Supplement: Pep2dia

Pep2Dia - dosage 2

ACTIVE COMPARATOR

1400mg of whey protein hydrolysates single dose

Dietary Supplement: Pep2dia

Placebo

PLACEBO COMPARATOR

maltodextrin single dose

Dietary Supplement: maltodextrin

Interventions

Pep2dia DIETARY_SUPPLEMENT

what is the effect of Pep2dia on postprandial glycemia after a meal rich in carbohydrates (75g)

Pep2Dia - dosage 2; Pep2dia- dosage 1

maltodextrin DIETARY_SUPPLEMENT

maltodextrin

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% - 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%)
• Body mass index 19-35 kg/m2
• Non-smoker
• Caucasian
• Availability and presence in the study units for approx. 3.5 hours/ week for 3 times.
• Signed informed consent form
• No changes in food habits or physical activity 3 months prior to screening and during the study

You may not qualify if:

• Presence of disease or drug(s) influencing digestion and absorption of nutrients or bowel habits
• Intake of medications known to affect glucose tolerance, e.g., diabetic medication, steroids, protease inhibitors or antipsychotics
• Diagnosed Typ 2-Diabetics with medical treatment
• 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, renal or cardiac disease
• Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks
• Known inflammatory and 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 antibiotics within 4 weeks before the test days
• Known alcohol abuse or drug abuse
• Pregnant or breast feeding women
• Known or suspected allergy to any component of the investigational product(s) (e.g. milk protein)
• Known HIV-infection
• Known acute or chronic hepatitis B and C infection

Sponsors & Collaborators

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

Study Sites (1)

Biotesys

Esslingen am Neckar, Germany

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

maltodextrin

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will be performed as a multicentric, randomized, double-blind, and placebo-controlled in a 3-way cross-over design.

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 5, 2020
• Study Start: May 4, 2020
• Primary Completion: July 25, 2020
• Study Completion: December 15, 2020
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)