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Insulin SensitivityPRODIGENCT02961179

Dairy Products, Diabetes and Genetics

A study testing Increased dairy product and Dietary counselling in people with Insulin Sensitivity and Type2 Diabetes, run by CHU de Quebec-Universite Laval at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Insulin Sensitivity, Type2 Diabetes
What is being tested?
Increased dairy product and Dietary counselling
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
1 siteCanada
Study dates
Jan 2017to 13 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
Show all 9Show fewer
  • 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 locations and contacts

1 site in 1 country.

Canada1 site

  • Research Center CHU de Quebec-Université Laval

    Québec, Quebec, G1V 4G2

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Increased dairy product, Dietary counselling
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Increased dairy productBehavioural

  • Dietary counsellingBehavioural

Study groups in NCT02961179
Study groupRoleWhat they receive
Increased dairy productExperimentalSubjects 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.
Receives: Behavioral: Increased dairy product
Dietary counsellingPlacebo comparatorSubjects will review the standard dietary recommendation(http://www.diabetes.ca/diabetes-and-you/nutrition/meal-planning-guide/) by a registered dietitian.
Receives: Behavioral: Dietary counselling

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    2h-oral glucose tolerance test (OGTT)

    Measured: Change from 0 to 6 weeks

Secondary outcomes (16)

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

    Measured: 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

    Measured: 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

    Insulinogenic index

    Measured: Change from 0 to 6 weeks

  4. 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

    Measured: Change from 0 to 6 weeks

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

    Measured: 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

    Measured: Change from 0 to 6 weeks

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

    Dual-energy X-ray absorptiometry

    Measured: Change from 0 to 6 weeks

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Change from 0 to 6 weeks

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

    Measured: 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

    Measured: Change from 0 to 6 weeks

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

    Measured: Change from 0 to 6 weeks

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

    Measured: Change from 0 to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2016 (estimated)
  2. Study startJan 2017
  3. Primary completion13 Jul 2018
  4. Study completion13 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02961179
Sponsor's protocol ID
2017-3228
Acronym
PRODIGE
Status last verified
Jan 2018
First submitted
3 Nov 2016
Last updated
1 Mar 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Arghavani H, Bilodeau JF, Rudkowska I. Impact of dairy intake on circulating fatty acids and associations with blood pressure: A randomized crossover trial. Nutr Metab Cardiovasc Dis. 2025 Sep;35(9):104112. doi: 10.1016/j.numecd.2025.104112. Epub 2025 Apr 30.

    PubMed 40436701

  • Khorraminezhad L, Rudkowska I. Modulation of gene expression profile following consumption of high-dairy products in subjects with hyperinsulinemia. Nutr Metab Cardiovasc Dis. 2023 Jan;33(1):219-226. doi: 10.1016/j.numecd.2022.10.015. Epub 2022 Nov 1.

    PubMed 36411217

  • 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.

    PubMed 35220313

  • 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.

    PubMed 31453424

Questions about this trial

What is this clinical trial studying?

A study testing Increased dairy product and Dietary counselling in people with Insulin Sensitivity and Type2 Diabetes, run by CHU de Quebec-Universite Laval at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to 6 weeks in insulin sensitivity between high dairy and dietary counselling phases (time frame: Change from 0 to 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02961179, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.

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