Dairy Products, Diabetes and Genetics (PRODIGE)

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

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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes; Insulin Sensitivity
• Intervention / Treatment: Behavioral: Increased dairy product; Behavioral: Dietary counselling

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G2
    • Research Center CHU de Quebec-Université Laval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Increased dairy product
Placebo Comparator: Dietary counselling; Subjects will review the standard dietary recommendation(http://www.diabetes.ca/diabetes-and-you/nutrition/meal-planning-guide/) by a registered dietitian.	Behavioral: Dietary counselling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 insulin secretion (Insulinogenic index ) between high dairy and dietary counselling phases	Insulinogenic index	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	Area under the curve of C-peptide	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 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 fat mass between high dairy and dietary counselling phases	Dual-energy X-ray absorptiometry	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 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 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 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 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 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 metabolomics profiles between high dairy and dietary counselling phases		Change from 0 to 6 weeks

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Collaborators: Canadian Institutes of Health Research (CIHR)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): July 13, 2018
• Study Completion (Actual): July 13, 2018

Study Registration Dates

• First Submitted: November 3, 2016
• First Submitted That Met QC Criteria: November 9, 2016
• First Posted (Estimate): November 10, 2016

Study Record Updates

• Last Update Posted (Actual): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: 2017-3228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No