Effects of Yoghurt Consumption on Glucose Metabolism in Prediabetic Subjects (SNOWFALL)

Danone Global Research & Innovation Center

Status: Not yet enrolling

Conditions: Prediabetes

Treatments: Other: Milk; Other: Yoghurt

Study type: Interventional

Funder types: Industry

Identifiers

NCT06836752

23REX0060026

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Yoghurt

Experimental group

Description:

2% fat yoghurt. Subjects will consume two servings (125 g/serving) of the test product per day.

Treatment:

Other: Yoghurt

Milk

Placebo Comparator group

Description:

2% fat cow's milk. Subjects will consume two servings (125 g/serving) of the control product per day.

Treatment:

Other: Milk