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

D

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)

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

Trial contacts and locations

1

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Central trial contact

Danone Global Research & Innovation Center

Data sourced from clinicaltrials.gov

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