Investigation of Milk Peptides on Postprandial Blood Glucose Profile

Postprandial Hyperglycemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03932695
• Other study ID #: BTS1130/17
• Status: Completed
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: April 2019
• Source: Ingredia S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 30, 2019
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia
• Postprandial Hyperglycemia

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)
• High Dose milk peptide
what is the effect of milk peptides 2800mg on postprandial glycemia after a meal rich in carbohydrates (75g)
• Placebo
what is the effect of placebo on postprandial glycemia after a meal rich in carbohydrates (75g)

Locations

Country	Name	City	State
Germany	Biotesys	Esslingen

Sponsors (1)

Lead Sponsor	Collaborator
Ingredia S.A.

Country where clinical trial is conducted

Germany, 

Outcome

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