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
Sponsored by
About this trial
This is an interventional prevention trial 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.
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
No
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
No
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
No
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
Learn more about this trial
Dairy Products, Diabetes and Genetics
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