Clinical Study to Assess the Long-term Effect of Pep2Dia® on Glucose Homeostasis in Prediabetic Subjects

Prediabetic State Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05391854
• Other study ID #: BTS1777/21
• Status: Completed
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: June 20, 2023

Study information

• Verified date: June 2023
• Source: Ingredia S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: June 20, 2023
• Est. primary completion date: May 5, 2023
• 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% 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

Related Conditions & MeSH terms

• Prediabetic State

Intervention

Dietary Supplement:
• Pep2dia
700 mg Pep2Dia® 15 min prior to breakfast and 700 mg Pep2Dia® 15 min prior to dinner
• Placebo
700 mg placebo 15 min prior to breakfast and 700 mg placebo 15 min prior to dinner

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	Glycated haemoglobin (HbA1c)	Change from baseline Glycated haemoglobin (HbA1c) at 3 months	Before treatment (baseline = day 0); at the end of the treatment (after 3 months = day 85)
Secondary	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 85
Secondary	Cmax	Maximum blood glucose concentration	Day 1; Day 85
Secondary	Delta Cmax	Maximum increase of glucose (Cmax minus baseline value)	Day 1; Day 85
Secondary	Tmax	Time to reach maximum blood glucose concentration	Day 1; Day 85
Secondary	Tbaseline	First time to reach baseline again after increase or decrease in blood glucose	Day 1; Day 85
Secondary	ISI 0-120min		Day 1; Day 85
Secondary	hsCRP		Day 1; Day 85
Secondary	GLP-1		Day 1; Day 85
Secondary	Body composition measurement	Evaluation of the fat mass/lean mass ratio by bioelectrical impedance analysis	Day 1; Day 85
Secondary	SF-12 (Short-fom 12)	Score from 12 to 60. Higher score mean a better outcome.	Day 1; Day 85