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Investigation of Milk Peptides on Postprandial Blood Glucose Profile

Primary Purpose

Postprandial Hyperglycemia

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Low dose milk peptide

High Dose milk peptide

Placebo

About this trial

This is an interventional prevention trial for Postprandial Hyperglycemia

Eligibility Criteria

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

Inclusion Criteria:

Male and female subjects with prediabetic HbA1c values between 5.7% - 6.4% and/or Fasting blood glucose ≥ 5.6 mmol/l (≥ 100 mg/dl) und < 7.0 mmol/l (< 125 mg/dl) (in venous plasma)
Age: 30-70 years
Body mass index 19-35 kg/m2
Non-smoker
Caucasian
Availability and presence in the study unit for approx. 3.5 hours/ week for 3 times in a row with approx. 1 week of washout in between.
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
Participation in a clinical study with an investigational product within one month before start of study

Sites / Locations

Biotesys

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

High dose Milk peptides

Low dose Milk peptides

Placebo

Arm Description

2800mg of whey protein hydrolysates single dose

1400mg of whey protein hydrolysate Single dose and 6 weeks intervention

maltodextrin

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

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

Insulin-iAUC(0-180min)

Area under the curve calculated as the incremental area under the Insulin response curve, ignoring the area beneath the fasting concentration

Cmax Baseline Insulin Max_increase Insulin

Max_increase Insulin Cmax minus baseline insulin value

Tmax insulin

time to reach maximum Insulin concentration

Fasting glucose, fasting insulin

HOMA index

Parameters of insulin sensitivity:

HbA1c level

HbA1c level after 6 weeks of supplementation

Matsuda index

Insulin sensitivity

Quicki Index

Insulin sensitivity

Full Information

NCT ID

NCT03932695

First Posted

April 24, 2019

Last Updated

May 13, 2019

Sponsor

Ingredia S.A.

1. Study Identification

Unique Protocol Identification Number

NCT03932695

Brief Title

Investigation of Milk Peptides on Postprandial Blood Glucose Profile

Official Title

Investigation of Milk Peptides on Postprandial Blood Glucose Profile: Randomized, Double-blind, Placebo-controlled, Cross-over Study With Different Dosages Followed by an Open-label Single Arm Phase to Estimate Long Term Effects

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

September 26, 2018 (Actual)

Primary Completion Date

February 20, 2019 (Actual)

Study Completion Date

April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ingredia S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Aim of the study is to investigate the effect of two different dosages of milk peptides on postprandial blood glucose profile in prediabetic subjects compared to placebo. This will be investigated in a cross-over double blind randomized placebo controlled study design. Additionally, long term effects on glucose status, insulin sensitivity and postprandial blood glucose profile will be investigated in a follow up 6-week open label phase with the low dose only.

6. Conditions and Keywords

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

Postprandial Hyperglycemia

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

double blind cross over and open for the phase II of the study

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

first phase of the study is RCT double blind placebo cross-over. The second phase is open during 6 weeks of supplementation

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High dose Milk peptides

Arm Type

Active Comparator

Arm Description

2800mg of whey protein hydrolysates single dose

Arm Title

Low dose Milk peptides

Arm Type

Active Comparator

Arm Description

1400mg of whey protein hydrolysate Single dose and 6 weeks intervention

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

maltodextrin

Intervention Type

Dietary Supplement

Intervention Name(s)

Low dose milk peptide

Intervention Description

what is the effect of milk peptides 1400mg on postprandial glycemia after a meal rich in carbohydrates (75g)

Intervention Type

Dietary Supplement

Intervention Name(s)

High Dose milk peptide

Intervention Description

what is the effect of milk peptides 2800mg on postprandial glycemia after a meal rich in carbohydrates (75g)

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

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

Time Frame

day 1, day 8, day 15, day 57

Secondary Outcome Measure Information:

Title

Cmax

Description

Maximum blood glucose concentration

Time Frame

day 1, day 8, day 15, day 57

Title

Max-Increase

Description

Cmax minus baseline value

Time Frame

day 1, day 8, day 15, day 57

Title

Tmax

Description

Time to reach maximum blood glucose concentration

Time Frame

day 1, day 8, day 15, day 57

Title

Tbaseline

Description

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

Time Frame

day 1, day 8, day 15, day 57

Title

AUC(0-180min):

Description

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

Time Frame

day 1, day 8, day 15, day 57

Title

Insulin-iAUC(0-180min)

Description

Area under the curve calculated as the incremental area under the Insulin response curve, ignoring the area beneath the fasting concentration

Time Frame

day 1, day 8, day 15, day 57

Title

Cmax Baseline Insulin Max_increase Insulin

Description

Max_increase Insulin Cmax minus baseline insulin value

Time Frame

day 1, day 8, day 15, day 57

Title

Tmax insulin

Description

time to reach maximum Insulin concentration

Time Frame

day 1, day 8, day 15, day 57

Title

Fasting glucose, fasting insulin

Time Frame

Baseline and Day 57

Title

HOMA index

Description

Parameters of insulin sensitivity:

Time Frame

Baseline and Day 57

Title

HbA1c level

Description

HbA1c level after 6 weeks of supplementation

Time Frame

Baseline (V5) and Day 57 (after 6 weeks)

Title

Matsuda index

Description

Insulin sensitivity

Time Frame

Baseline and Day 57

Title

Quicki Index

Description

Insulin sensitivity

Time Frame

Baseline and Day 57

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female subjects with prediabetic HbA1c values between 5.7% - 6.4% and/or Fasting blood glucose ≥ 5.6 mmol/l (≥ 100 mg/dl) und < 7.0 mmol/l (< 125 mg/dl) (in venous plasma) Age: 30-70 years Body mass index 19-35 kg/m2 Non-smoker Caucasian Availability and presence in the study unit for approx. 3.5 hours/ week for 3 times in a row with approx. 1 week of washout in between. 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 Participation in a clinical study with an investigational product within one month before start of study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Audrey BOULIER, MD

Organizational Affiliation

Ingredia S.A.

Official's Role

Principal Investigator

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 on Postprandial Blood Glucose Profile

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