DRIVE: Dairy and Inflammation Study

Sponsor

York University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04902417

Collaborator

Dairy Farmers of Canada (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation Overweight and Obesity Cardiometabolic Risk	Other: Dairy Foods (Yoghurt, Cheese, Milk)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Two-phase, randomized, controlled, crossover trial design.Two-phase, randomized, controlled, crossover trial design.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Fasting Inflammation [pre-intervention]
Concentration of Interleukin-6
Fasting Inflammation [immediately after the 6 week intervention]
Concentration of Interleukin-6
Postprandial Inflammation [1 hour post meal]
Concentration of Interleukin-6
Postprandial Inflammation [2 hour post meal]
Concentration of Interleukin-6
Postprandial Inflammation [3 hour post meal]
Concentration of Interleukin-6
Postprandial Inflammation [4 hour post meal]
Concentration of Interleukin-6
Postprandial Inflammation [5 hour post meal]
Concentration of Interleukin-6

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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