Dairy Products, Diabetes and Genetics
Not Applicable
Completed
- Conditions
- Insulin SensitivityType2 Diabetes
- Interventions
- Behavioral: Increased dairy productBehavioral: Dietary counselling
- 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
- Arm && Interventions
Group Intervention Description Increased dairy product Increased dairy product Subjects will be asked to consume a total of 3 to 5 servings per day.They will be instructed on options and variations for incorporating the dairy foods into their routine dietary pattern. Dietary counselling Dietary counselling Subjects will review the standard dietary recommendation(http://www.diabetes.ca/diabetes-and-you/nutrition/meal-planning-guide/) by a registered dietitian.
- 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 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 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
Trial Locations
- Locations (1)
Research Center CHU de Quebec-Université Laval
🇨🇦Quebec, Canada