NCT06836752

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

September 16, 2025

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

29 days

First QC Date

January 13, 2025

Last Update Submit

January 9, 2026

Conditions

Prediabetes

Keywords

Randomized controlled trialPrediabetes

Outcome Measures

Primary Outcomes (3)

  • Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) calculated as fasting serum insulin (FSI) levels (mU/L) multiplied by fasting plasma glucose (FPG) levels (mmol/L) divided by 22.5.

    Change from Baseline to Week 24

  • Change in FPG [mmol/L]

    Change from Baseline to Week 24

  • Change in 2-h post load Glucose Area Under the Curve (AUC) [mmol/L· min] measured during 2-hour oral glucose tolerance test (OGTT)

    Change from Baseline to Week 24

Secondary Outcomes (32)

  • Change in Body Weight [kg]

    Change from Baseline to Week 12 and to Week 24

  • Change in Body Mass Index (BMI) [kg/m²] as calculated by body weight (kg) divided by square of height (m)

    Change from Baseline to Week 12 and to Week 24

  • Change in Waist Circumference [cm]

    Change from Baseline to Week 12 and to Week 24

  • Change in Fat Mass as measured by Bioelectrical Impedance Analysis (BIA) [kg]

    Change from Baseline to Week 24

  • Change in Fat Mass Percentage as measured by BIA (%)

    Change from Baseline to Week 24

  • +27 more secondary outcomes

Study Arms (2)

Yoghurt

EXPERIMENTAL

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

Other: Yoghurt

Milk

PLACEBO COMPARATOR

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

Other: Milk

Interventions

YoghurtOTHER

250 g per day

Yoghurt
MilkOTHER

250 g per day

Milk

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed ICF
  • Male/Female 18-65 years
  • BMI 25-35 kg/m2
  • FPG 100-125 mg/dL
  • At least one relative with T2DM
  • BW maintained (\<3%)
  • Female postmenopausal or sterile or using contraceptive method
  • Ability to comply with study protocol form
  • Access to a refrigerator at home for study products storage
  • Ability to collect and store stool samples
  • Coverage by French health insurance
  • Agreement to be registered in the national database of subjects participating in clinical research
  • Ability to complete ePRO
  • FPG 100-125 mg/dL at randomisation visit

You may not qualify if:

  • Diagnosis of T2DM, T1DM, or on antidiabetic medications
  • Medications or supplements affecting gut microbiota or causing hyperglycemia
  • Systemic antibiotic treatment
  • Treatment interfering with BW and bariatric surgery
  • Liver, renal, cardiovascular, respiratory, endocrine, metabolic disorders, or iatrogenic immunodeficiency
  • Chronic gastro-intestinal disorders or recent use of laxatives
  • Recent surgery or general anesthesia
  • Donation/Loss of blood
  • Inability to comply with dietary restriction
  • Allergy or intolerance to study product ingredients
  • Excessive consumption of alcohol
  • Smoker
  • Pregnancy, breast-feeding or change in contraceptive methods
  • Situation interfering with optimal participation
  • Participation in other clinical study
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hôpitaux de Paris

Paris, France

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

YogurtMilk

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Cultured Milk ProductsBeveragesDiet, Food, and NutritionPhysiological PhenomenaFermented FoodsDairy ProductsFoodFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomised, open label, controlled, parallel-group
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2025

First Posted

February 20, 2025

Study Start

September 16, 2025

Primary Completion

October 15, 2025

Study Completion

October 15, 2025

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)