## Protocol Section
### Identification Module
**NCT ID:** NCT02961179

**Acronym:** PRODIGE

**Brief Title:** Dairy Products, Diabetes and Genetics

**Official Title:** Nutrigenomics Approach to Investigate the Benefits of Dairy Product Consumption on Glucose Homeostasis

#### Organization Study ID Info
**ID:** 2017-3228
#### Organization
**Class:** OTHER
**Full Name:** CHU de Quebec-Universite Laval
### Status Module
#### Completion Date
**Date:** 2018-07-13

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-03-01

**Type:** ACTUAL

**Last Update Submit Date:** 2019-02-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-07-13

**Type:** ACTUAL

#### Start Date
**Date:** 2017-01

**Type:** ACTUAL

**Status Verified Date:** 2018-01

#### Study First Post Date
**Date:** 2016-11-10
**Type:** ESTIMATED
**Study First Submit Date:** 2016-11-03
**Study First Submit QC Date:** 2016-11-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Canadian Institutes of Health Research (CIHR)

#### Lead Sponsor

**Class:** OTHER

**Name:** CHU de Quebec-Universite Laval

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Insulin Sensitivity

- Type2 Diabetes

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 33

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Behavioral: Increased dairy product

**Label:** Increased dairy product

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Behavioral: Dietary counselling

**Label:** Dietary counselling

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Increased dairy product

**Name:** Increased dairy product

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Dietary counselling

**Name:** Dietary counselling

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 2h-oral glucose tolerance test (OGTT)

**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

#### Secondary Outcomes

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

**Time Frame:** Change from 0 to 6 weeks

**Measure:** 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

**Description:** Insulinogenic index

**Measure:** 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

**Description:** Area under the curve of C-peptide

**Measure:** 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

**Measure:** 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

**Measure:** 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

**Description:** Dual-energy X-ray absorptiometry

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

**Time Frame:** Change from 0 to 6 weeks

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

**Time Frame:** Change from 0 to 6 weeks

**Measure:** 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

**Measure:** 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

**Measure:** 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

**Measure:** 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

**Measure:** 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

**Measure:** 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

**Measure:** 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

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

**Time Frame:** Change from 0 to 6 weeks

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Quebec

**Country:** Canada

**Facility:** Research Center CHU de Quebec-Université Laval

**Zip:** G1V 4G2

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 35220313

**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.

**PMID:** 31453424

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006946

- Term: Hyperinsulinism

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10370

- Name: Insulin Resistance

- Relevance: HIGH

- As Found: Insulin Sensitivity

- ID: M9997

- Name: Hyperinsulinism

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007333

- Term: Insulin Resistance

### Misc Info Module

- Version Holder: 2024-05-24
