Clinical trial NCT05391854: Clinical Study to Assess the Long-term Effect of Pep2Dia® on Glucose Homeostasis in Prediabetic Subjects
Official title: Clinical Study to Assess the Long-term Effect of Pep2Dia® on Glucose Homeostasis in Prediabetic Subjects: a 12-week Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel Study
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: 2022-05-26
Enrollment: 128
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal is to assess the long-term effect of Pep2Dia® compared to placebo intake on blood glucose homeostasis. Respective improvements will be assessed by changes in glycated haemoglobin (HbA1c) before and after the 12-weeks intervention.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects (minimum one third of each gender) with prediabetic HbA1c values between 5.7% and 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%)
* Age: 25-70 years
* Body mass index 19-35 kg/m2
* Current Non-smoker
* Availability and presence in the study units for approx. 3.5 hours/ week for 2 times.
* Signed informed consent form
* No changes in food habits or physical activity 3 months prior to screening and during the study
* If applicable, stable intake of chronic medication of at least 4 weeks

Exclusion Criteria:

* Subjects with diagnosed Type 2-Diabetes with medical treatment
* Presence of disease or drug(s) influencing digestion and absorption of nutrients
* Intake of medications known to affect glucose tolerance, e.g., diabetic medication SGLT-2 inhibitors, GLP-1 receptor agonists, steroids, protease inhibitors or antipsychotics
* 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 or renal disease or laboratory evidence of hepatic dysfunction (i.e. alkaline phosphatase, ALT, AST \>3 x ULN)
* Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks
* Known inflammatory or 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 food supplements known to affect glucose tolerance, e.g., cinnamon capsules, conjugated linoleic acids, omega-3 fatty acids
* Intake of antibiotics within 4 weeks before the test days
* Known alcohol abuse or drug abuse
* Pregnant or breast-feeding women
* Weight loss intervention or recent body weight change \>5 kg during last 3 months
* Known or suspected allergy to any component of the investigational product(s) (e.g. milk protein)
* Blood donation within 4 weeks prior to Visit 1 or during the study
* Anticipating any planned changes in lifestyle for the duration of the study
* Participation in another clinical intervention study within the last 4 weeks and concurrent participation in another intervention clinical study
* Subject unable to co-operate adequately

Primary outcomes:
measure: Glycated haemoglobin (HbA1c)
timeFrame: Before treatment (baseline = day 0); at the end of the treatment (after 3 months = day 85)
Secondary outcomes:
measure: Glucose-iAUC(0-180min)
timeFrame: Day 1; Day 85
measure: Cmax
timeFrame: Day 1; Day 85
measure: Delta Cmax
timeFrame: Day 1; Day 85
measure: Tmax
timeFrame: Day 1; Day 85
measure: Tbaseline
timeFrame: Day 1; Day 85
measure: ISI 0-120min
timeFrame: Day 1; Day 85
measure: hsCRP
timeFrame: Day 1; Day 85
measure: GLP-1
timeFrame: Day 1; Day 85
measure: Body composition measurement
timeFrame: Day 1; Day 85
measure: SF-12 (Short-fom 12)
timeFrame: Day 1; Day 85
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: Biotesys
Study officials:
References: