Effects of Yoghurt Consumption on Glucose Metabolism in Prediabetic Subjects

Launched by DANONE GLOBAL RESEARCH & INNOVATION CENTER · Feb 14, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how eating yoghurt may affect blood sugar levels in people who are at risk of developing type 2 diabetes, a condition known as prediabetes. Researchers want to see if including yoghurt in one's diet can improve how the body processes glucose, which is the sugar found in our blood. The study is not yet recruiting participants, but they are seeking individuals aged between 18 and 65 who have a body mass index (BMI) between 25 and 35 and whose fasting blood glucose levels are between 100 and 125 mg/dL. It’s also important that participants have a family history of type 2 diabetes.

To participate, individuals will need to meet certain criteria, like being able to store study products in a refrigerator and complete some dietary requirements. Participants will also need to provide stool samples and have French health insurance coverage. Throughout the study, participants can expect to follow a specific diet and help researchers understand the potential benefits of yoghurt for managing blood sugar. If you or someone you know fits these criteria and is interested in contributing to this research, it could be a great opportunity to help advance our understanding of diabetes prevention.

Gender

ALL

Eligibility 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