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The current operational setting is not sustainable and very unlikely to deliver the planned enrollment of 60 participants. Even with significant protocol amendments, these challenges would remain.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoghurt | Experimental | 2% fat yoghurt. Subjects will consume two servings (125 g/serving) of the test product per day. |
|
| Milk | Placebo Comparator | 2% fat cow's milk. Subjects will consume two servings (125 g/serving) of the control product per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoghurt | Other | 250 g per day |
| |
| Milk |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique - Hôpitaux de Paris | Paris | France |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015014 | Yogurt |
| D008892 | Milk |
| ID | Term |
|---|---|
| D043302 | Cultured Milk Products |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Randomised, open label, controlled, parallel-group
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| Other |
250 g per day |
|
| 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 |
| Change in Visceral Adipose Tissue mass [g] as measured by BIA [g] | Change from Baseline to Week 24 |
| Change in Fat Free Mass as measured by BIA [kg] | Change from Baseline to Week 24 |
| Change in fasting plasma Glycated Haemoglobin A1c (HbA1C) [%] | Change from Baseline to Week 12 and to Week 24 |
| Change in FSI levels [mU/L] | 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 | Change from Baseline to Week 12 |
| Change in FPG levels [mmol/L] | 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] | 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] | 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 | 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) | 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]) | 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 | 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 | 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 | 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) | Change from Baseline to Week 24 |
| Change in plasma Alanine Aminotransferase (ALAT) [U/L]) | Change from Baseline to Week 12 and to Week 24 |
| Change in plasma Aspartate Aminotransferase (ASAT) [U/L]) | 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))) | Change from Baseline to Week 12 and to Week 24 |
| Change in fasting serum Total Cholesterol (TC) [mmol/L] | Change from Baseline to Week 12 and to Week 24 |
| Change in fasting serum High Density Lipoprotein (HDL) [mmol/L] | Change from Baseline to Week 12 and to Week 24 |
| Change in fasting serum Low Density Lipoprotein (LDL) [mmol/L] | Change from Baseline to Week 12 and to Week 24 |
| Change in fasting serum Triglycerides (TG) [mmol/L] | 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] | 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] | 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) | 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 | Change from Baseline to Week 24 |
| Change in Gut microbiota function as measured by fecal microbial pathways abundances using metagenomic approach | Change from Baseline to Week 24 |
| D004700 | Endocrine System Diseases |
| D000074421 |
| Fermented Foods |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |