Dairy Products, Diabetes and Genetics

Type2 Diabetes Clinical Trial

— PRODIGE  

Official title:

Nutrigenomics Approach to Investigate the Benefits of Dairy Product Consumption on Glucose Homeostasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02961179
• Other study ID #: 2017-3228
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: July 13, 2018

Study information

• Verified date: January 2018
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 13, 2018
• Est. primary completion date: July 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity
• Type2 Diabetes

Intervention

Behavioral:
• Increased dairy product

• Dietary counselling

Locations

Country	Name	City	State
Canada	Research Center CHU de Quebec-Université Laval	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to 6 weeks in insulin sensitivity between high dairy and dietary counselling phases	2h-oral glucose tolerance test (OGTT)	Change from 0 to 6 weeks
Secondary	Change from baseline to 6 weeks in fasting glucose between high dairy and dietary counselling phases		Change from 0 to 6 weeks
Secondary	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
Secondary	Change from baseline to 6 weeks in insulin secretion (Insulinogenic index ) between high dairy and dietary counselling phases	Insulinogenic index	Change from 0 to 6 weeks
Secondary	Change from baseline to 6 weeks in insulin secretion (area under the curve of C-peptide) between high dairy and dietary counselling phases	Area under the curve of C-peptide	Change from 0 to 6 weeks
Secondary	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
Secondary	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
Secondary	Change from baseline to 6 weeks in fat mass between high dairy and dietary counselling phases	Dual-energy X-ray absorptiometry	Change from 0 to 6 weeks
Secondary	Change from baseline to 6 weeks in blood pressure between high dairy and dietary counselling phases		Change from 0 to 6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline to 6 weeks in fatty acid profile between high dairy and dietary counselling phases		Change from 0 to 6 weeks
Secondary	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
Secondary	Change from baseline to 6 weeks in gene expression profiles between high dairy and dietary counselling phases		Change from 0 to 6 weeks
Secondary	Change from baseline to 6 weeks in metabolomics profiles between high dairy and dietary counselling phases		Change from 0 to 6 weeks