Dairy Products, Diabetes and Genetics
Not Applicable
Completed
- Conditions
- Insulin SensitivityType2 Diabetes
- Registration Number
- NCT02961179
- Lead Sponsor
- CHU de Quebec-Universite Laval
- Brief Summary
This study will investigate the in-depth the benefits of dairy consumption on glucose metabolism in patients at risk of type 2 diabetes using novel genomics methodology.To do so, 33 individuals at risk of type 2 diabetes will be randomly subjected to an intervention study including a 6-week intensive dairy product consumption period and a 6-week dietary counselling period.
- Detailed Description
More than 9 million Canadians are living with diabetes or prediabetes. Type 2 diabetes is a disorder characterized by high blood glucose. Dietary modification is a key component in type 2 diabetes management. For example, dairy product consumption has beneficial effects on metabolic health. Yet, researchers have shown that mixed results exists for insulin sensitivity.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
- Caucasian men and postmenopausal women (absence of menstrual cycles for >12 months) aged >18 yrs;
- BMI between 25-40 kg/m2;
- Hyperinsulinemia (fasting plasma insulin >90 pmol/l);
- Fasting plasma glucose (FPG) <7.0 mmol/l; HbA1c <6.5%);
- If treated with lipid-lowering agents, the dose must have been stable over the last 3 months;
- Stable body weight (±5%) for 3 months;
- Willing to consume study foods and able to follow protocol and give informed consent.
Exclusion Criteria
- Failure to meet any one or more of the inclusion criteria;
- Diagnosis of type 2 diabetes;
- High dairy consumption ( 2 servings/day or more);
- Major surgery in the 3 months prior to study onset;
- Smoking;
- Incompatibility with dairy consumption (allergy, intolerance or dislike);
- Inflammatory bowel disease or other gastrointestinal disorder influencing gastrointestinal motility or nutrient absorption;
- Medications known to affect lipid and glucose metabolism other than those used to treat hypertension or dyslipidemia;
- Diseases known to affect glucose metabolism.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Change from baseline to 6 weeks in insulin sensitivity between high dairy and dietary counselling phases Change from 0 to 6 weeks 2h-oral glucose tolerance test (OGTT)
- Secondary Outcome Measures
Name Time Method Change from baseline to 6 weeks in fasting glucose between high dairy and dietary counselling phases Change from 0 to 6 weeks Change from baseline to 6 weeks in fat mass between high dairy and dietary counselling phases Change from 0 to 6 weeks Dual-energy X-ray absorptiometry
Change from baseline to 6 weeks in aortic stiffness (pulse wave velocity) between high dairy and dietary counselling phases Change from 0 to 6 weeks Change from baseline to 6 weeks in inflammatory profile (C-reactive protein, Tumor necrosis factor-alpha, Interleukin-6) between high dairy and dietary counselling phases Change from 0 to 6 weeks Change from baseline to 6 weeks in serum 25(OH) vitamin D between high dairy and dietary counselling phases Change from 0 to 6 weeks Change from baseline to 6 weeks in gene expression profiles between high dairy and dietary counselling phases Change from 0 to 6 weeks Change from baseline to 6 weeks in b-cell function (disposition index) between high dairy and dietary counselling phases Change from 0 to 6 weeks Change from baseline to 6 weeks in blood pressure between high dairy and dietary counselling phases Change from 0 to 6 weeks Change from baseline to 6 weeks in 2 h plasma glucose post OGTT between high dairy and dietary counselling phases Change from 0 to 6 weeks Change from baseline to 6 weeks in lipid profile (total-cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) between high dairy and dietary counselling phases Change from 0 to 6 weeks Change from baseline to 6 weeks in metabolomics profiles between high dairy and dietary counselling phases Change from 0 to 6 weeks Change from baseline to 6 weeks in insulin secretion (area under the curve of C-peptide) between high dairy and dietary counselling phases Change from 0 to 6 weeks Area under the curve of C-peptide
Change from baseline to 6 weeks in glucagon-like peptide-1 secretion between high dairy and dietary counselling phases Change from 0 to 6 weeks Change from baseline to 6 weeks in insulin secretion (Insulinogenic index ) between high dairy and dietary counselling phases Change from 0 to 6 weeks Insulinogenic index
Change from baseline to 6 weeks in oxidative stress profile (F2-isoprostane profiles) between high dairy and dietary counselling phases Change from 0 to 6 weeks Change from baseline to 6 weeks in fatty acid profile between high dairy and dietary counselling phases Change from 0 to 6 weeks
Trial Locations
- Locations (1)
Research Center CHU de Quebec-Université Laval
🇨🇦Quebec, Canada
Research Center CHU de Quebec-Université Laval🇨🇦Quebec, Canada