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Dairy Products, Diabetes and Genetics (PRODIGE)

Primary Purpose

Insulin Sensitivity, Type2 Diabetes

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Increased dairy product

Dietary counselling

About this trial

This is an interventional prevention trial for Insulin Sensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Research Center CHU de Quebec-Université Laval

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Increased dairy product

Dietary counselling

Arm 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.

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

Outcomes

Primary Outcome Measures

Change from baseline to 6 weeks in insulin sensitivity between high dairy and dietary counselling phases

2h-oral glucose tolerance test (OGTT)

Secondary Outcome Measures

Change from baseline to 6 weeks in fasting glucose between high dairy and dietary counselling phases

Change from baseline to 6 weeks in 2 h plasma glucose post OGTT between high dairy and dietary counselling phases

Change from baseline to 6 weeks in insulin secretion (Insulinogenic index ) between high dairy and dietary counselling phases

Insulinogenic index

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 baseline to 6 weeks in b-cell function (disposition index) between high dairy and dietary counselling phases

Change from baseline to 6 weeks in glucagon-like peptide-1 secretion between high dairy and dietary counselling phases

Change from baseline to 6 weeks in fat mass between high dairy and dietary counselling phases

Dual-energy X-ray absorptiometry

Change from baseline to 6 weeks in blood pressure between high dairy and dietary counselling phases

Change from baseline to 6 weeks in aortic stiffness (pulse wave velocity) between high dairy and dietary counselling phases

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 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 baseline to 6 weeks in oxidative stress profile (F2-isoprostane profiles) between high dairy and dietary counselling phases

Change from baseline to 6 weeks in fatty acid profile between high dairy and dietary counselling phases

Change from baseline to 6 weeks in serum 25(OH) vitamin D between high dairy and dietary counselling phases

Change from baseline to 6 weeks in gene expression profiles between high dairy and dietary counselling phases

Change from baseline to 6 weeks in metabolomics profiles between high dairy and dietary counselling phases

Full Information

NCT ID

NCT02961179

First Posted

November 3, 2016

Last Updated

February 28, 2019

Sponsor

CHU de Quebec-Universite Laval

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT02961179

Brief Title

Dairy Products, Diabetes and Genetics

Acronym

PRODIGE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

January 2017 (Actual)

Primary Completion Date

July 13, 2018 (Actual)

Study Completion Date

July 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CHU de Quebec-Universite Laval

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin Sensitivity, Type2 Diabetes

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Increased dairy product

Arm Type

Experimental

Arm 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.

Arm Title

Dietary counselling

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Increased dairy product

Intervention Type

Behavioral

Intervention Name(s)

Dietary counselling

Primary Outcome Measure Information:

Title

Change from baseline to 6 weeks in insulin sensitivity between high dairy and dietary counselling phases

Description

2h-oral glucose tolerance test (OGTT)

Time Frame

Change from 0 to 6 weeks

Secondary Outcome Measure Information:

Title

Change from baseline to 6 weeks in fasting glucose between high dairy and dietary counselling phases

Time Frame

Change from 0 to 6 weeks

Title

Change from baseline to 6 weeks in 2 h plasma glucose post OGTT between high dairy and dietary counselling phases

Time Frame

Change from 0 to 6 weeks

Title

Change from baseline to 6 weeks in insulin secretion (Insulinogenic index ) between high dairy and dietary counselling phases

Description

Insulinogenic index

Time Frame

Change from 0 to 6 weeks

Title

Change from baseline to 6 weeks in insulin secretion (area under the curve of C-peptide) between high dairy and dietary counselling phases

Description

Area under the curve of C-peptide

Time Frame

Change from 0 to 6 weeks

Title

Change from baseline to 6 weeks in b-cell function (disposition index) between high dairy and dietary counselling phases

Time Frame

Change from 0 to 6 weeks

Title

Change from baseline to 6 weeks in glucagon-like peptide-1 secretion between high dairy and dietary counselling phases

Time Frame

Change from 0 to 6 weeks

Title

Change from baseline to 6 weeks in fat mass between high dairy and dietary counselling phases

Description

Dual-energy X-ray absorptiometry

Time Frame

Change from 0 to 6 weeks

Title

Change from baseline to 6 weeks in blood pressure between high dairy and dietary counselling phases

Time Frame

Change from 0 to 6 weeks

Title

Change from baseline to 6 weeks in aortic stiffness (pulse wave velocity) between high dairy and dietary counselling phases

Time Frame

Change from 0 to 6 weeks

Title

Change from baseline to 6 weeks in lipid profile (total-cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) between high dairy and dietary counselling phases

Time Frame

Change from 0 to 6 weeks

Title

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

Time Frame

Change from 0 to 6 weeks

Title

Change from baseline to 6 weeks in oxidative stress profile (F2-isoprostane profiles) between high dairy and dietary counselling phases

Time Frame

Change from 0 to 6 weeks

Title

Change from baseline to 6 weeks in fatty acid profile between high dairy and dietary counselling phases

Time Frame

Change from 0 to 6 weeks

Title

Change from baseline to 6 weeks in serum 25(OH) vitamin D between high dairy and dietary counselling phases

Time Frame

Change from 0 to 6 weeks

Title

Change from baseline to 6 weeks in gene expression profiles between high dairy and dietary counselling phases

Time Frame

Change from 0 to 6 weeks

Title

Change from baseline to 6 weeks in metabolomics profiles between high dairy and dietary counselling phases

Time Frame

Change from 0 to 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Research Center CHU de Quebec-Université Laval

City

Quebec

ZIP/Postal Code

G1V 4G2

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35220313

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.

Results Reference

derived

PubMed Identifier

31453424

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.

Results Reference

derived

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Dairy Products, Diabetes and Genetics

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