Back to results

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

Primary Purpose

Prediabetic State

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Pep2dia

maltodextrin

About this trial

This is an interventional prevention trial for Prediabetic State

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Blood donation within 4 weeks prior to visit 1 or during the study
Subject unable to co-operate adequately

Sites / Locations

Biotesys

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pep2dia- dosage 1

Pep2Dia - dosage 2

Placebo

Arm Description

700mg of whey protein hydrolysates single dose

1400mg of whey protein hydrolysates single dose

maltodextrin single dose

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Cmax

Maximum blood glucose concentration

Max_increase

Cmax minus baseline value

Tmax

Time to reach maximum blood glucose concentration

Tbaseline

First time to reach baseline again after increase or decrease in blood glucose

AUC(0-180min)

Total area under curve from 0 to 180 min for blood glucose concentration

Matsuda index

Marker of insulin sensitivity

Increase of insulin

Area under the curve calculated as the incremental area under the Insulin response curve, ignoring the area beneath the fasting concentration (Insulin-iAUC(0-180min)). If applicable further pharmacokinetic data from insulin increase will be calculated (e.g. Cmax, Tmax)

GLP-1-iAUC(0-120min)

120 min postprandial incretin response in terms of Glucagon-like Peptide-1

Full Information

NCT ID

NCT04375449

First Posted

May 1, 2020

Last Updated

May 5, 2022

Sponsor

Ingredia S.A.

Collaborators

BioTeSys GmbH

1. Study Identification

Unique Protocol Identification Number

NCT04375449

Brief Title

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

Official Title

Investigation of Milk Peptides (Pep2Dia®) on Postprandial Blood Glucose Profile in Prediabetic Subjects: Randomized, Double-blind, Placebo-controlled, Cross-over Study With Different Dosages

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

May 4, 2020 (Actual)

Primary Completion Date

July 25, 2020 (Actual)

Study Completion Date

December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ingredia S.A.

Collaborators

BioTeSys GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

From a previous pilot study (BTS1130/17) there is first evidence that the native whey product with alpha-glucosidase inhibiting properties (Pep2Dia®) has the potential to modulate postprandial hyperglycaemia in prediabetic subjects. Thereby, incremental areas under the curve (iAUC) of glucose as the primary outcome were significantly reduced by a single dosage of 1400 mg Pep2Dia® compared to placebo the second study 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. Furthermore, the 120 min postprandial incretin response in terms of Glucagon-like Peptide-1 (GLP-1) will be determined. Changes in insulin sensitivity will be determined by the Matsuda-index as appropriate outcome measure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prediabetic State

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pep2dia- dosage 1

Arm Type

Active Comparator

Arm Description

700mg of whey protein hydrolysates single dose

Arm Title

Pep2Dia - dosage 2

Arm Type

Active Comparator

Arm Description

1400mg of whey protein hydrolysates single dose

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

maltodextrin single dose

Intervention Type

Dietary Supplement

Intervention Name(s)

Pep2dia

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

maltodextrin

Intervention Description

maltodextrin

Primary Outcome Measure Information:

Title

Glucose-iAUC(0-180min)

Description

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)

Time Frame

Day 1, Day 15, Day 29

Secondary Outcome Measure Information:

Title

Cmax

Description

Maximum blood glucose concentration

Time Frame

Day 1, Day 15, Day 29

Title

Max_increase

Description

Cmax minus baseline value

Time Frame

Day 1, Day 15, Day 29

Title

Tmax

Description

Time to reach maximum blood glucose concentration

Time Frame

Day 1, Day 15, Day 29

Title

Tbaseline

Description

First time to reach baseline again after increase or decrease in blood glucose

Time Frame

Day 1, Day 15, Day 29

Title

AUC(0-180min)

Description

Total area under curve from 0 to 180 min for blood glucose concentration

Time Frame

Day 1, Day 15, Day 29

Title

Matsuda index

Description

Marker of insulin sensitivity

Time Frame

Day 1, Day 15, Day 29

Title

Increase of insulin

Description

Time Frame

Day 1, Day 15, Day 29

Title

GLP-1-iAUC(0-120min)

Description

120 min postprandial incretin response in terms of Glucagon-like Peptide-1

Time Frame

Day 1, Day 15, Day 29

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Blood donation within 4 weeks prior to visit 1 or during the study Subject unable to co-operate adequately

Facility Information:

Facility Name

Biotesys

City

Esslingen

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs