Investigation of Milk Peptides on Postprandial Blood Glucose Profile

NCT03932695 | Completed

• 1 other identifier: BTS1130/17
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprandial Hyperglycemia

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

  day 1, day 8, day 15, day 57

Secondary Outcomes (13)

• Cmax

  day 1, day 8, day 15, day 57

• Max-Increase

  day 1, day 8, day 15, day 57

• Tmax

  day 1, day 8, day 15, day 57

• Tbaseline

  day 1, day 8, day 15, day 57

• AUC(0-180min):

  day 1, day 8, day 15, day 57

Study Arms (3)

High dose Milk peptides

ACTIVE COMPARATOR

2800mg of whey protein hydrolysates single dose

Dietary Supplement: High Dose milk peptide

Low dose Milk peptides

ACTIVE COMPARATOR

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

Dietary Supplement: Low dose milk peptide

Placebo

PLACEBO COMPARATOR

maltodextrin

Dietary Supplement: Placebo

Interventions

Low dose milk peptide DIETARY_SUPPLEMENT

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

Low dose Milk peptides

High Dose milk peptide DIETARY_SUPPLEMENT

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

High dose Milk peptides

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Study Sites (1)

Biotesys

Esslingen am Neckar, Germany

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Audrey BOULIER, MD

  Ingredia S.A.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: first phase of the study is RCT double blind placebo cross-over. The second phase is open during 6 weeks of supplementation
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 1, 2019
• Study Start: September 26, 2018
• Primary Completion: February 20, 2019
• Study Completion: April 30, 2019
• Last Updated: May 14, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)