Dairy and Inflammation Study (DRIVE)

Influence of Increased Dairy Product Consumption on Markers of Inflammation and Cardiometabolic Disease

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Inflammation; Overweight and Obesity; Cardiometabolic Risk
• Intervention / Treatment: Other: Dairy Foods (Yoghurt, Cheese, Milk)

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M3J 1P3
      • York University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Low Dairy Habitual Diet; Participants will follow their usual diet for 6-weeks, which includes low dairy consumption as screened for with the inclusion criteria.
Experimental: High Dairy Diet; 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	Other: Dairy Foods (Yoghurt, Cheese, Milk); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Inflammation	Concentration of Interleukin-6	pre-intervention
Fasting Inflammation	Concentration of Interleukin-6	immediately after the 6 week intervention
Postprandial Inflammation	Concentration of Interleukin-6	1 hour post meal
Postprandial Inflammation	Concentration of Interleukin-6	2 hour post meal
Postprandial Inflammation	Concentration of Interleukin-6	3 hour post meal
Postprandial Inflammation	Concentration of Interleukin-6	4 hour post meal
Postprandial Inflammation	Concentration of Interleukin-6	5 hour post meal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Lipids	Concentration of serum cholesterol	pre-intervention
Fasting Lipids	Concentration of serum cholesterol	immediately after the 6 week intervention
Fasting Lipids	Concentration of serum triglycerides	pre-intervention
Fasting Lipids	Concentration of serum triglycerides	immediately after the 6 week intervention
Fasting glucose	Concentration of blood glucose	pre-intervention
Fasting glucose	Concentration of blood glucose	immediately after the 6 week intervention
Fasting insulin	Concentration of blood insulin	pre-intervention
Fasting insulin	Concentration of blood insulin	immediately after the 6 week intervention
vascular measures	flow-mediated dilation (FMD)	pre-intervention
vascular measures	flow-mediated dilation (FMD)	immediately after the 6 week intervention
Body composition	fat mass (kg)	pre-intervention
Body composition	fat mass (kg)	immediately after the 6 week intervention

Collaborators and Investigators

• Sponsor: York University
• Collaborators: Dairy Farmers of Canada
• Investigators: Study Director: Lauren E Skelly, PhD, York University; Study Director: Joel Prowting, MSc, York University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Inflammation; Dairy; Diet; postprandial
• Additional Relevant MeSH Terms: Pathologic Processes; Overnutrition; Nutrition Disorders; Body Weight; Inflammation; Overweight
• Other Study ID Numbers: 2021-177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No