Clinical trial NCT04375449: Investigation of Milk Peptides (Pep2Dia®) on Postprandial Blood Glucose Profile in Prediabetic Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State
Lead sponsor: Ingredia S.A.
Sponsor class: INDUSTRY
Collaborators: name: BioTeSys GmbH
First posted: 2020-05-05
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study will be performed as a multicentric, randomized, double-blind, and placebo-controlled in a 3-way cross-over design.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Glucose-iAUC(0-180min)
timeFrame: Day 1, Day 15, Day 29
Secondary outcomes:
measure: Cmax
timeFrame: Day 1, Day 15, Day 29
measure: Max_increase
timeFrame: Day 1, Day 15, Day 29
measure: Tmax
timeFrame: Day 1, Day 15, Day 29
measure: Tbaseline
timeFrame: Day 1, Day 15, Day 29
measure: AUC(0-180min)
timeFrame: Day 1, Day 15, Day 29
measure: Matsuda index
timeFrame: Day 1, Day 15, Day 29
measure: Increase of insulin
timeFrame: Day 1, Day 15, Day 29
measure: GLP-1-iAUC(0-120min)
timeFrame: Day 1, Day 15, Day 29
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: Biotesys
Study officials:
References: