SNOWFALLYoghurt Effects on Glucose Metabolism in High-Risk Type 2 Diabetes
Yoghurt
+ Milk
Diabetes Mellitus+3
+ Endocrine System Diseases
+ Metabolic Diseases
Basic Science Study
Summary
Study start date: September 16, 2025
Actual date on which the first participant was enrolled.This study aims to explore how consuming yogurt over 24 weeks affects glucose metabolism in people who are at high risk of developing type 2 diabetes. Participants are adults between the ages of 18 and 65, who are overweight with a body mass index (BMI) between 25 and 35. They have been diagnosed with prediabetes, meaning their blood sugar levels are higher than normal but not high enough yet to be classified as diabetes. The study seeks to understand if yogurt consumption can influence blood sugar levels and potentially help in preventing the onset of type 2 diabetes. Participants will first enter a two-week period where they avoid all dairy products and supplements containing live bacteria like probiotics. After this, they will be divided into two groups for the main 24-week period. One group will consume yogurt regularly, while the other group will not. The study will monitor and compare the blood sugar levels and other related health markers of these groups to assess the impact of yogurt on glucose metabolism. This research could provide insights into dietary recommendations for people at risk of diabetes.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.8 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Signed ICF 2. Male/Female 18-65 years 3. BMI 25-35 kg/m2 4. FPG 100-125 mg/dL 5. At least one relative with T2DM 6. BW maintained (\<3%) 7. Female postmenopausal or sterile or using contraceptive method 8. Ability to comply with study protocol form 9. Access to a refrigerator at home for study products storage 10. Ability to collect and store stool samples 11. Coverage by French health insurance 12. Agreement to be registered in the national database of subjects participating in clinical research 13. Ability to complete ePRO 14. FPG 100-125 mg/dL at randomisation visit Exclusion Criteria: 1. Diagnosis of T2DM, T1DM, or on antidiabetic medications 2. Medications or supplements affecting gut microbiota or causing hyperglycemia 3. Systemic antibiotic treatment 4. Treatment interfering with BW and bariatric surgery 5. Liver, renal, cardiovascular, respiratory, endocrine, metabolic disorders, or iatrogenic immunodeficiency 6. Chronic gastro-intestinal disorders or recent use of laxatives 7. Recent surgery or general anesthesia 8. Donation/Loss of blood 9. Inability to comply with dietary restriction 10. Allergy or intolerance to study product ingredients 11. Excessive consumption of alcohol 12. Smoker 13. Pregnancy, breast-feeding or change in contraceptive methods 14. Situation interfering with optimal participation 15. Participation in other clinical study 16. Living in the same home as another participant 17. Employees, family members of Danone
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Assistance Publique - Hôpitaux de Paris
Paris, FranceOpen Assistance Publique - Hôpitaux de Paris in Google Maps