Investigation of Milk Peptides (Pep2Dia®) on Postprandial Blood Glucose Profile in Prediabetic Subjects

Prediabetic State Clinical Trial

Official title:

Investigation of Milk Peptides (Pep2Dia®) on Postprandial Blood Glucose Profile in Prediabetic Subjects: Randomized, Double-blind, Placebo-controlled, Cross-over Study With Different Dosages

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04375449
• Other study ID #: BTS1472/20
• Status: Completed
• Phase: N/A
• Start date: May 4, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: May 2022
• Source: Ingredia S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal is to investigate the 180 min postprandial response on blood glucose and insulin levels after intake of Pep2Dia® in two different dosages compared to placebo in the context of a meal challenge test, providing 75 g of carbohydrates. Pep2Dia® will be administered 15 min prior to a standardized challenge meal.

Description:

From a previous pilot study (BTS1130/17) there is first evidence that the native whey product with alpha-glucosidase inhibiting properties (Pep2Dia®) has the potential to modulate postprandial hyperglycaemia in prediabetic subjects. Thereby, incremental areas under the curve (iAUC) of glucose as the primary outcome were significantly reduced by a single dosage of 1400 mg Pep2Dia® compared to placebo the second study is to investigate the 180 min postprandial response on blood glucose and insulin levels after intake of Pep2Dia® in two different dosages compared to placebo in the context of a meal challenge test, providing 75 g of carbohydrates. Pep2Dia® will be administered 15 min prior to a standardized challenge meal. Furthermore, the 120 min postprandial incretin response in terms of Glucagon-like Peptide-1 (GLP-1) will be determined. Changes in insulin sensitivity will be determined by the Matsuda-index as appropriate outcome measure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 15, 2020
• Est. primary completion date: July 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male and female subjects (minimum one third of each gender) with prediabetic HbA1c values between 5.7% - 6.4% and/or fasting glucose = 5.6 mmol/L (= 100 mg/dL) and < 7.0 mmol/L (< 125 mg/dL) (in venous plasma) (twice confirmed at two independent days if HbA1c is < 5.7%)
• Body mass index 19-35 kg/m2
• Non-smoker
• Caucasian
• Availability and presence in the study units for approx. 3.5 hours/ week for 3 times.
• 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

Related Conditions & MeSH terms

• Prediabetic State

Intervention

Dietary Supplement:
• Pep2dia
what is the effect of Pep2dia on postprandial glycemia after a meal rich in carbohydrates (75g)
• maltodextrin
maltodextrin

Locations

Country	Name	City	State
Germany	Biotesys	Esslingen

Sponsors (2)

Lead Sponsor	Collaborator
Ingredia S.A.	BioTeSys GmbH

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 (according to ISO 26642:2010(E)	Day 1, Day 15, Day 29
Secondary	Cmax	Maximum blood glucose concentration	Day 1, Day 15, Day 29
Secondary	Max_increase	Cmax minus baseline value	Day 1, Day 15, Day 29
Secondary	Tmax	Time to reach maximum blood glucose concentration	Day 1, Day 15, Day 29
Secondary	Tbaseline	First time to reach baseline again after increase or decrease in blood glucose	Day 1, Day 15, Day 29
Secondary	AUC(0-180min)	Total area under curve from 0 to 180 min for blood glucose concentration	Day 1, Day 15, Day 29
Secondary	Matsuda index	Marker of insulin sensitivity	Day 1, Day 15, Day 29
Secondary	Increase of insulin	Area under the curve calculated as the incremental area under the Insulin response curve, ignoring the area beneath the fasting concentration (Insulin-iAUC(0-180min)). If applicable further pharmacokinetic data from insulin increase will be calculated (e.g. Cmax, Tmax)	Day 1, Day 15, Day 29
Secondary	GLP-1-iAUC(0-120min)	120 min postprandial incretin response in terms of Glucagon-like Peptide-1	Day 1, Day 15, Day 29