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Completed

NCT Number: NCT02961179

Dairy Products, Diabetes and Genetics

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Center CHU de Quebec-Université Laval

Québec, Quebec, G1V 4G2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Increased dairy product

Behavioral

Dietary counselling

Behavioral

Primary outcomes

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

    Time frame: Change from 0 to 6 weeks

    2h-oral glucose tolerance test (OGTT)

Secondary outcomes

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

    Time frame: Change from 0 to 6 weeks

  2. 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

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

    Time frame: Change from 0 to 6 weeks

    Insulinogenic index

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

    Time frame: Change from 0 to 6 weeks

    Area under the curve of C-peptide

  5. 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

  6. 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

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

    Time frame: Change from 0 to 6 weeks

    Dual-energy X-ray absorptiometry

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

    Time frame: Change from 0 to 6 weeks

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

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

    Time frame: Change from 0 to 6 weeks

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Acronym: PRODIGE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 10, 2016
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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