Dairy Products, Diabetes and Genetics

NCT ID: NCT02961179

Last Updated: 2019-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-07-13

Brief Summary

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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

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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.

Conditions

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Insulin Sensitivity Type2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Increased dairy product

Intervention Type BEHAVIORAL

Dietary counselling

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

Group Type PLACEBO_COMPARATOR

Dietary counselling

Intervention Type BEHAVIORAL

Interventions

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Increased dairy product

Intervention Type BEHAVIORAL

Dietary counselling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Center CHU de Quebec-Université Laval

Québec, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 40436701 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36411217 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35220313 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31453424 (View on PubMed)

Other Identifiers

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2017-3228

Identifier Type: -

Identifier Source: org_study_id

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