Investigation of Milk Peptides on Postprandial Blood Glucose Profile

Not Applicable

Completed

• Conditions: Postprandial Hyperglycemia
• Interventions: Dietary Supplement: High Dose milk peptide; Dietary Supplement: Placebo; Dietary Supplement: Low dose milk peptide

• Registration Number: NCT03932695
• Lead Sponsor: Ingredia S.A.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-26
• Primary Completion: 2019-02-20
• Status Verified: 2019-04
• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-04-29
• Study Completion: 2019-04-30
• Study First Posted: 2019-05-01
• Last Update Submitted: 2019-05-13
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High dose Milk peptides	High Dose milk peptide	2800mg of whey protein hydrolysates single dose
Placebo	Placebo	maltodextrin
Low dose Milk peptides	Low dose milk peptide	1400mg of whey protein hydrolysate Single dose and 6 weeks intervention

Primary Outcome Measures

Name	Time	Method
Glucose-iAUC(0-180min)	day 1, day 8, day 15, day 57	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

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

Trial Locations

Locations (1)

Biotesys; 🇩🇪 Esslingen, Germany