Effects of Yoghurt Consumption on Glucose Metabolism in Prediabetic Subjects

NCT ID: NCT06836752

Last Updated: 2026-01-12

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-16

Study Completion Date

2025-10-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Prediabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised, open label, controlled, parallel-group
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

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.

Group Type EXPERIMENTAL

Yoghurt

Intervention Type OTHER

250 g per day

Milk

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

Group Type PLACEBO_COMPARATOR

Milk

Intervention Type OTHER

250 g per day

Interventions

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Yoghurt

250 g per day

Intervention Type OTHER

Milk

250 g per day

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Assistance Publique - Hôpitaux de Paris

Paris, , France

Site Status

Countries

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France

Other Identifiers

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23REX0060026

Identifier Type: -

Identifier Source: org_study_id

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