Prediabetes
Conditions
Keywords
Randomized controlled trial, Prediabetes
Brief summary
The purpose of this study is to explore the effects of yoghurt consumption on glucose metabolism in prediabetic subjects.
Detailed 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.
Interventions
OTHERYoghurt
250 g per day
OTHERMilk
250 g per day
Sponsors
Danone Global Research & Innovation Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Randomised, open label, controlled, parallel-group
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 Gut microbiota function as measured by fecal microbial pathways abundances using metagenomic approach | 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 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 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 |
Countries
France
Outcome results
None listed