Dairy Products, Diabetes and Genetics (PRODIGE)

Laval University

Status: Completed

Conditions: Type2 Diabetes; Insulin Sensitivity

Treatments: Behavioral: Dietary counselling; Behavioral: Increased dairy product

Study type: Interventional

Funder types: Other

Identifiers

NCT02961179

2017-3228

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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33 participants in 2 patient groups, including a placebo group

Increased dairy product

Experimental group

Description:

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.

Treatment:

Behavioral: Increased dairy product

Dietary counselling

Placebo Comparator group

Description:

Subjects will review the standard dietary recommendation(http://www.diabetes.ca/diabetes-and-you/nutrition/meal-planning-guide/) by a registered dietitian.

Treatment:

Behavioral: Dietary counselling