Overview
The purpose of this study is to explore the effects of yoghurt consumption on glucose metabolism in prediabetic subjects.
Description
Study population: the study population will consist of 60 (30 per group) subjects (men and women) at high risk of type 2 diabetes mellitus (T2DM), aged 18-65 years (inclusive), body mass index (BMI) 25.0 (inclusive) - 35.0 kg/m2 (exclusive), diagnosed with prediabetes, defined as fasting plasma glucose levels 100-125 mg/dL (5.6-6.9 mmol/L) (inclusive), randomised in a test and control group.
Intervention comprises of two study periods: a refrain period from dairy products and pro-, pre- and synbiotic supplements in any form, for 2 weeks, followed by an intervention period of 24 weeks.
Eligibility
Inclusion Criteria:
- Signed ICF
- Male/Female 18-65 years
- BMI 25-35 kg/m2
- FPG 100-125 mg/dL
- At least one relative with T2DM
- BW maintained (<3%)
- Female postmenopausal or sterile or using contraceptive method
- Ability to comply with study protocol form
- Access to a refrigerator at home for study products storage
- Ability to collect and store stool samples
- Coverage by French health insurance
- Agreement to be registered in the national database of subjects participating in clinical research
- Ability to complete ePRO
- FPG 100-125 mg/dL at randomisation visit
Exclusion Criteria:
- Diagnosis of T2DM, T1DM, or on antidiabetic medications
- Medications or supplements affecting gut microbiota or causing hyperglycemia
- Systemic antibiotic treatment
- Treatment interfering with BW and bariatric surgery
- Liver, renal, cardiovascular, respiratory, endocrine, metabolic disorders, or iatrogenic immunodeficiency
- Chronic gastro-intestinal disorders or recent use of laxatives
- Recent surgery or general anesthesia
- Donation/Loss of blood
- Inability to comply with dietary restriction
- Allergy or intolerance to study product ingredients
- Excessive consumption of alcohol
- Smoker
- Pregnancy, breast-feeding or change in contraceptive methods
- Situation interfering with optimal participation
- Participation in other clinical study
- Living in the same home as another participant
- Employees, family members of Danone