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Dairy and Inflammation Study (DRIVE)

Primary Purpose

Inflammation, Overweight and Obesity, Cardiometabolic Risk

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dairy Foods (Yoghurt, Cheese, Milk)
Sponsored by
York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation focused on measuring Dairy, Diet, Inflammation, postprandial

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body mass index (BMI) ≥ 25 kg/m2
  • ≤ 2 structured exercise sessions/week
  • Habitual low dairy consumption (≤ 1 serving/day)
  • Having at least two other metabolic risk factors based on clinical guidelines:

    • Elevated blood pressure (≥130/≥85 mm Hg)
    • Impaired fasting glucose (≥5.6 mmol/L) measured using a finger prick sample
    • Impaired fasting triglycerides (≥1.7 mmol/L) or high-density lipoprotein (<1.03 mmol/L for males, <1.3 mmol/L for females) measured using a finger prick blood sample.
    • Increased waist circumference (≥102 cm for males and ≥88 cm for females).
    • Borderline high fasting low-density lipoprotein (≥3.5 mmol/L) or total cholesterol (≥5.2 mmol/L).

Exclusion Criteria:

  • Allergy to dairy foods, diagnosed lactose intolerance or an aversion to foods provided during the study
  • Previous history of diabetes and/or related cardiovascular disease
  • The use of multiple medications for managing lipids, glucose and/or blood pressure

Sites / Locations

  • York UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Low Dairy Habitual Diet

High Dairy Diet

Arm Description

Participants will follow their usual diet for 6-weeks, which includes low dairy consumption as screened for with the inclusion criteria.

Participants will be provided with 3 servings of dairy per day to replace other foods within their diet (preventing weight gain over the intervention period) for 6-weeks

Outcomes

Primary Outcome Measures

Fasting Inflammation
Concentration of Interleukin-6
Fasting Inflammation
Concentration of Interleukin-6
Postprandial Inflammation
Concentration of Interleukin-6
Postprandial Inflammation
Concentration of Interleukin-6
Postprandial Inflammation
Concentration of Interleukin-6
Postprandial Inflammation
Concentration of Interleukin-6
Postprandial Inflammation
Concentration of Interleukin-6

Secondary Outcome Measures

Fasting Lipids
Concentration of serum cholesterol
Fasting Lipids
Concentration of serum cholesterol
Fasting Lipids
Concentration of serum triglycerides
Fasting Lipids
Concentration of serum triglycerides
Fasting glucose
Concentration of blood glucose
Fasting glucose
Concentration of blood glucose
Fasting insulin
Concentration of blood insulin
Fasting insulin
Concentration of blood insulin
vascular measures
flow-mediated dilation (FMD)
vascular measures
flow-mediated dilation (FMD)
Body composition
fat mass (kg)
Body composition
fat mass (kg)

Full Information

First Posted
May 11, 2021
Last Updated
August 25, 2023
Sponsor
York University
Collaborators
Dairy Farmers of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT04902417
Brief Title
Dairy and Inflammation Study
Acronym
DRIVE
Official Title
Influence of Increased Dairy Product Consumption on Markers of Inflammation and Cardiometabolic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
York University
Collaborators
Dairy Farmers of Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether 6-weeks of increased dairy consumption can reduce inflammation and other markers of chronic disease while fasted or following a high-fat meal.
Detailed Description
Following the acquisition of informed consent, eligibility to participate in the study will be determined using questionnaires, and certain parameters determined from a finger-prick blood sample. Eligible participants will be assigned to complete two 6-week dietary interventions in random order, with at least a 4 week "wash out" period (i.e. their habitual eating) in between. The two dietary interventions are: 1) Participants normal, low-dairy diet; and 2) A higher dairy diet where 3 servings per day of dairy foods are provided. Prior to beginning either 6-week diet intervention, participants will be asked to attend the laboratory at York University after an overnight fast to undergo baseline testing. Following baseline testing, participants will meet with a registered dietitian (RD) to discuss each diet arm. Specifically, if they are on the dairy diet, participants will receive advice on how to incorporate these dairy foods into their diet by replacing other foods of similar energy content so as to not increase their total energy intake and body weight. They will meet with the RD at several other times throughout the study. During each 6-week diet period, they will be asked to keep their physical activity levels constant and to not adopt any other major dietary changes during the study. At the end of each 6-week intervention period, participants will be asked to return to York University to repeat the initial set of tests performed at baseline. In addition to the fasted tests, a number of tests will be performed after asking participants to consume a high-fat test meal (i.e. a fast-food breakfast). Various measurements will continue to be taken for around 6 hours after this meal is consumed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Overweight and Obesity, Cardiometabolic Risk
Keywords
Dairy, Diet, Inflammation, postprandial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Two-phase, randomized, controlled, crossover trial design.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Dairy Habitual Diet
Arm Type
No Intervention
Arm Description
Participants will follow their usual diet for 6-weeks, which includes low dairy consumption as screened for with the inclusion criteria.
Arm Title
High Dairy Diet
Arm Type
Experimental
Arm Description
Participants will be provided with 3 servings of dairy per day to replace other foods within their diet (preventing weight gain over the intervention period) for 6-weeks
Intervention Type
Other
Intervention Name(s)
Dairy Foods (Yoghurt, Cheese, Milk)
Intervention Description
Participants will be provided with a combination of dairy products (Yoghurt, Cheese, Milk) to be consumed daily, for a total of 3 servings per day
Primary Outcome Measure Information:
Title
Fasting Inflammation
Description
Concentration of Interleukin-6
Time Frame
pre-intervention
Title
Fasting Inflammation
Description
Concentration of Interleukin-6
Time Frame
immediately after the 6 week intervention
Title
Postprandial Inflammation
Description
Concentration of Interleukin-6
Time Frame
1 hour post meal
Title
Postprandial Inflammation
Description
Concentration of Interleukin-6
Time Frame
2 hour post meal
Title
Postprandial Inflammation
Description
Concentration of Interleukin-6
Time Frame
3 hour post meal
Title
Postprandial Inflammation
Description
Concentration of Interleukin-6
Time Frame
4 hour post meal
Title
Postprandial Inflammation
Description
Concentration of Interleukin-6
Time Frame
5 hour post meal
Secondary Outcome Measure Information:
Title
Fasting Lipids
Description
Concentration of serum cholesterol
Time Frame
pre-intervention
Title
Fasting Lipids
Description
Concentration of serum cholesterol
Time Frame
immediately after the 6 week intervention
Title
Fasting Lipids
Description
Concentration of serum triglycerides
Time Frame
pre-intervention
Title
Fasting Lipids
Description
Concentration of serum triglycerides
Time Frame
immediately after the 6 week intervention
Title
Fasting glucose
Description
Concentration of blood glucose
Time Frame
pre-intervention
Title
Fasting glucose
Description
Concentration of blood glucose
Time Frame
immediately after the 6 week intervention
Title
Fasting insulin
Description
Concentration of blood insulin
Time Frame
pre-intervention
Title
Fasting insulin
Description
Concentration of blood insulin
Time Frame
immediately after the 6 week intervention
Title
vascular measures
Description
flow-mediated dilation (FMD)
Time Frame
pre-intervention
Title
vascular measures
Description
flow-mediated dilation (FMD)
Time Frame
immediately after the 6 week intervention
Title
Body composition
Description
fat mass (kg)
Time Frame
pre-intervention
Title
Body composition
Description
fat mass (kg)
Time Frame
immediately after the 6 week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body mass index (BMI) ≥ 25 kg/m2 ≤ 2 structured exercise sessions/week Habitual low dairy consumption (≤ 1 serving/day) Having at least two other metabolic risk factors based on clinical guidelines: Elevated blood pressure (≥130/≥85 mm Hg) Impaired fasting glucose (≥5.6 mmol/L) measured using a finger prick sample Impaired fasting triglycerides (≥1.7 mmol/L) or high-density lipoprotein (<1.03 mmol/L for males, <1.3 mmol/L for females) measured using a finger prick blood sample. Increased waist circumference (≥102 cm for males and ≥88 cm for females). Borderline high fasting low-density lipoprotein (≥3.5 mmol/L) or total cholesterol (≥5.2 mmol/L). Exclusion Criteria: Allergy to dairy foods, diagnosed lactose intolerance or an aversion to foods provided during the study Previous history of diabetes and/or related cardiovascular disease The use of multiple medications for managing lipids, glucose and/or blood pressure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea R Josse, PhD
Phone
14167362100
Ext
30038
Email
ajosse@yorku.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Joel Prowting, MSc
Phone
14167362100
Ext
33990
Email
jprowt@yorku.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren E Skelly, PhD
Organizational Affiliation
York University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joel Prowting, MSc
Organizational Affiliation
York University
Official's Role
Study Director
Facility Information:
Facility Name
York University
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 1P3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea R Josse, PhD
Phone
4167362100
Ext
30038
Email
ajosse@yorku.ca
First Name & Middle Initial & Last Name & Degree
Joel L Prowting, MSc
Phone
4167362100
Ext
33990
Email
jprowt@yorku.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Dairy and Inflammation Study

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