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NCT06836752 | RECRUITING | Prediabetes

Effects of Yoghurt Consumption on Glucose Metabolism in Prediabetic Subjects
Sponsor:

Danone Global Research & Innovation Center

Brief Summary:

The purpose of this study is to explore the effects of yoghurt consumption on glucose metabolism in prediabetic subjects.

Condition or disease

Prediabetes

Intervention/treatment

Yoghurt

Milk

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : A Randomised, Open Label, Controlled, Parallel-group Study to Explore the Effects of 24 Weeks Intake of Yoghurt on Glucose Metabolism in Subjects at High Risk of Type 2 Diabetes Mellitus
Actual Study Start Date : 2025-10
Estimated Primary Completion Date : 2027-04
Estimated Study Completion Date : 2027-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
Effects of Yoghurt Consumption on Glucose Metabolism in Prediabetic Subjects

Location Details

NCT06836752

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

France,

Public assistance - Paris hospitals

Paris, France,