An interventional study of Yoghurt and Milk in Prediabetes, sponsored by Danone Global Research & Innovation Center. Terminated at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by Danone Global Research & Innovation Center · Not applicable, Interventional, and Basic science
The purpose of this study is to explore the effects of yoghurt consumption on glucose metabolism in prediabetic subjects.
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.
999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.
This study's enrollment of 8 is below the median of 65 across 844 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Danone Global Research & Innovation Center is the lead sponsor of 38 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2% fat yoghurt. Subjects will consume two servings (125 g/serving) of the test product per day.
Other: Yoghurt
2% fat cow's milk. Subjects will consume two servings (125 g/serving) of the control product per day.
Other: Milk
250 g per day
250 g per day
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.
Time frame: Change from Baseline to Week 24
Change in FPG [mmol/L]
Time frame: 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)
Time frame: Change from Baseline to Week 24
Change in Body Weight [kg]
Time frame: 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)
Time frame: Change from Baseline to Week 12 and to Week 24
Change in Waist Circumference [cm]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in Fat Mass as measured by Bioelectrical Impedance Analysis (BIA) [kg]
Time frame: Change from Baseline to Week 24
Change in Fat Mass Percentage as measured by BIA (%)
Time frame: Change from Baseline to Week 24
Change in Visceral Adipose Tissue mass [g] as measured by BIA [g]
Time frame: Change from Baseline to Week 24
Change in Fat Free Mass as measured by BIA [kg]
Time frame: Change from Baseline to Week 24
Change in fasting plasma Glycated Haemoglobin A1c (HbA1C) [%]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in FSI levels [mU/L]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in HOMA-IR calculated as FSI (mU/L) multiplied by FPG, (mmol/L) divided by 22.5
Time frame: Change from Baseline to Week 12
Change in FPG levels [mmol/L]
Time frame: Change from Baseline to Week 12
Change in Glucose tolerance as measured by plasma glucose at 30-, 60-, and 120-min post load during 2-hour OGTT [mmol/L]
Time frame: Change from Baseline to Week 24
Change in Insulin secretion as measured by serum insulin at 30-, 60-, and 120-min post load during 2-hour OGTT [mU/L]
Time frame: Change from Baseline to Week 24
Change in β-cell function as measured by Homeostatic Model Assessment of β-cell function (HOMA-β) calculated as follows: 20 x FSI levels (mU/L) divided by FPG levels (mmol/L) subtracted by 3.5
Time frame: Change from Baseline to Week 24
Change in β-cell response as measured by Insulinogenic index (IGI), calculated from the OGTT as delta serum insulin (0-30 min) (µU/mL) divided by delta plasma glucose (0-30 min) (mg/dL)
Time frame: Change from Baseline to Week 24
Change in whole-body insulin sensitivity as measured by Matsuda index, calculated from the OGTT as follows: (10,000/square root of (FPG (mg/dL) x FSI (mU/L)) x (mean plasma glucose (mg/dL) x mean serum insulin (mU/L) during OGTT])
Time frame: Change from Baseline to Week 24
Change in Disposition Index (DI), a composite marker of first phase insulin secretion and insulin sensitivity calculated from the OGTT as follows: Matsuda index * [AUC30min serum insulin (pmol/L) / AUC30min plasma glucose (mmol/L)], where AUC30min is the
Time frame: Change from Baseline to Week 24
Change in Muscle Insulin Sensitivity Index (MISI), calculated from the OGTT as the slope of the least square fit to the decline in plasma glucose concentration (mmol/L) from peak to nadir divided by the mean serum insulin (pmol/L) during OGTT
Time frame: Change from Baseline to Week 24
Change in Hepatic Insulin Resistance Index (HIRI) calculated from the OGTT as follows: the product of the plasma glucose (mmol/L) area under the curve and serum insulin (pmol/L) area under the curve during the first 30min of the OGTT
Time frame: Change from Baseline to Week 24
Change in fasting circulating concentrations of alpha-hydroxyisocaproic acid (HICA), alpha-hydroxyisovaleric acid (HIVA) and alpha-hydroxy-beta-methylvaleric acid (HMVA) (μmol/L)
Time frame: Change from Baseline to Week 24
Change in plasma Alanine Aminotransferase (ALAT) [U/L])
Time frame: Change from Baseline to Week 12 and to Week 24
Change in plasma Aspartate Aminotransferase (ASAT) [U/L])
Time frame: Change from Baseline to Week 12 and to Week 24
Change in Fibrosis 4 index (FIB-4) calculated as (Age (years) x ASAT (U/L) / (Platelets (109/L) x square root of ALAT (U/L)))
Time frame: Change from Baseline to Week 12 and to Week 24
Change in fasting serum Total Cholesterol (TC) [mmol/L]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in fasting serum High Density Lipoprotein (HDL) [mmol/L]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in fasting serum Low Density Lipoprotein (LDL) [mmol/L]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in fasting serum Triglycerides (TG) [mmol/L]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in Energy intake from 3 non-consecutives days of 24-h dietary recalls [kcal/day]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in macronutrients intake from 3 non-consecutives days of 24-h dietary recalls [g/day]
Time frame: Change from Baseline to Week 12 and to Week 24
Change in physical activity energy expenditure score as measured by Recent Physical Activity Questionnaire (Metabolic Equivalent of Task hours/day)
Time frame: Change from Baseline to Week 12 and to Week 24
Change in Gut microbiota composition as measured by fecal microbial alpha-diversity, beta diversity and taxa abundances using metagenomic approach
Time frame: Change from Baseline to Week 24
Change in Gut microbiota function as measured by fecal microbial pathways abundances using metagenomic approach
Time frame: Change from Baseline to Week 24
Plan to share: No
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This study is terminated, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Danone Global Research & Innovation Center