Effects of Yoghurt Consumption on Glucose Metabolism in Prediabetic Subjects
NCT ID: NCT06836752
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
8 participants
INTERVENTIONAL
2025-09-16
2025-10-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Yoghurt
2% fat yoghurt. Subjects will consume two servings (125 g/serving) of the test product per day.
Yoghurt
250 g per day
Milk
2% fat cow's milk. Subjects will consume two servings (125 g/serving) of the control product per day.
Milk
250 g per day
Interventions
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Yoghurt
250 g per day
Milk
250 g per day
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
Yes
Sponsors
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Danone Global Research & Innovation Center
INDUSTRY
Responsible Party
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Locations
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Assistance Publique - Hôpitaux de Paris
Paris, , France
Countries
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Other Identifiers
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23REX0060026
Identifier Type: -
Identifier Source: org_study_id
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