Investigation of Milk Peptides on Postprandial Blood Glucose Profile

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

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.

Study Overview

• Status: Completed
• Conditions: Postprandial Hyperglycemia
• Intervention / Treatment: Dietary supplement: High Dose milk peptide; Dietary supplement: Low dose milk peptide; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Esslingen, Germany
    • BioTeSys

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; maltodextrin	Dietary supplement: Placebo; what is the effect of placebo on postprandial glycemia after a meal rich in carbohydrates (75g)
Active Comparator: High dose Milk peptides; 2800mg of whey protein hydrolysates single dose	Dietary supplement: High Dose milk peptide; what is the effect of milk peptides 2800mg on postprandial glycemia after a meal rich in carbohydrates (75g)
Active Comparator: Low dose Milk peptides; 1400mg of whey protein hydrolysate Single dose and 6 weeks intervention	Dietary supplement: Low dose milk peptide; what is the effect of milk peptides 1400mg on postprandial glycemia after a meal rich in carbohydrates (75g)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	day 1, day 8, day 15, day 57

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum blood glucose concentration	day 1, day 8, day 15, day 57
Max-Increase	Cmax minus baseline value	day 1, day 8, day 15, day 57
Tmax	Time to reach maximum blood glucose concentration	day 1, day 8, day 15, day 57
Tbaseline	First time to reach baseline again after increase or decrease in blood glucose	day 1, day 8, day 15, day 57
AUC(0-180min):	Total area under curve from 0 to 180 min for blood glucose concentration	day 1, day 8, day 15, day 57
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	day 1, day 8, day 15, day 57
Cmax Baseline Insulin Max_increase Insulin	Max_increase Insulin Cmax minus baseline insulin value	day 1, day 8, day 15, day 57
Tmax insulin	time to reach maximum Insulin concentration	day 1, day 8, day 15, day 57
Fasting glucose, fasting insulin		Baseline and Day 57
HOMA index	Parameters of insulin sensitivity:	Baseline and Day 57
HbA1c level	HbA1c level after 6 weeks of supplementation	Baseline (V5) and Day 57 (after 6 weeks)
Matsuda index	Insulin sensitivity	Baseline and Day 57
Quicki Index	Insulin sensitivity	Baseline and Day 57

Collaborators and Investigators

• Sponsor: Ingredia S.A.
• Investigators: Principal Investigator: Audrey BOULIER, MD, Ingredia S.A.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2018
• Primary Completion (Actual): February 20, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: BTS1130/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No