Clinical trial NCT02961179: Dairy Products, Diabetes and Genetics
Official title: Nutrigenomics Approach to Investigate the Benefits of Dairy Product Consumption on Glucose Homeostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity
Type2 Diabetes
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2016-11-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline to 6 weeks in insulin sensitivity between high dairy and dietary counselling phases
timeFrame: Change from 0 to 6 weeks
Secondary outcomes:
measure: Change from baseline to 6 weeks in fasting glucose between high dairy and dietary counselling phases
timeFrame: Change from 0 to 6 weeks
measure: Change from baseline to 6 weeks in 2 h plasma glucose post OGTT between high dairy and dietary counselling phases
timeFrame: Change from 0 to 6 weeks
measure: Change from baseline to 6 weeks in insulin secretion (Insulinogenic index ) between high dairy and dietary counselling phases
timeFrame: Change from 0 to 6 weeks
measure: Change from baseline to 6 weeks in insulin secretion (area under the curve of C-peptide) between high dairy and dietary counselling phases
timeFrame: Change from 0 to 6 weeks
measure: Change from baseline to 6 weeks in b-cell function (disposition index) between high dairy and dietary counselling phases
timeFrame: Change from 0 to 6 weeks
measure: Change from baseline to 6 weeks in glucagon-like peptide-1 secretion between high dairy and dietary counselling phases
timeFrame: Change from 0 to 6 weeks
measure: Change from baseline to 6 weeks in fat mass between high dairy and dietary counselling phases
timeFrame: Change from 0 to 6 weeks
measure: Change from baseline to 6 weeks in blood pressure between high dairy and dietary counselling phases
timeFrame: Change from 0 to 6 weeks
measure: Change from baseline to 6 weeks in aortic stiffness (pulse wave velocity) between high dairy and dietary counselling phases
timeFrame: Change from 0 to 6 weeks
measure: Change from baseline to 6 weeks in lipid profile (total-cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) between high dairy and dietary counselling phases
timeFrame: Change from 0 to 6 weeks
measure: 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
timeFrame: Change from 0 to 6 weeks
measure: Change from baseline to 6 weeks in oxidative stress profile (F2-isoprostane profiles) between high dairy and dietary counselling phases
timeFrame: Change from 0 to 6 weeks
measure: Change from baseline to 6 weeks in fatty acid profile between high dairy and dietary counselling phases
timeFrame: Change from 0 to 6 weeks
measure: Change from baseline to 6 weeks in serum 25(OH) vitamin D between high dairy and dietary counselling phases
timeFrame: Change from 0 to 6 weeks
measure: Change from baseline to 6 weeks in gene expression profiles between high dairy and dietary counselling phases
timeFrame: Change from 0 to 6 weeks
measure: Change from baseline to 6 weeks in metabolomics profiles between high dairy and dietary counselling phases
timeFrame: Change from 0 to 6 weeks
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Research Center CHU de Quebec-Université Laval
Study officials:
References:
citation: Khorraminezhad L, Rudkowska I. Dairy Product Intake Modifies MicroRNA Expression among Individuals with Hyperinsulinemia: A Post-Intervention Cross-Sectional Study. Lifestyle Genom. 2022;15(3):77-86. doi: 10.1159/000523809. Epub 2022 Feb 25.
citation: O'Connor S, Julien P, Weisnagel SJ, Gagnon C, Rudkowska I. Impact of a High Intake of Dairy Product on Insulin Sensitivity in Hyperinsulinemic Adults: A Crossover Randomized Controlled Trial. Curr Dev Nutr. 2019 Jul 24;3(8):nzz083. doi: 10.1093/cdn/nzz083. eCollection 2019 Aug.