Dairy and Inflammation Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Inflammation, Overweight and Obesity, Cardiometabolic Risk

Intervention / Treatment
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* Other: Dairy Foods (Yoghurt, Cheese, Milk)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Two-phase, randomized, controlled, crossover trial design.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Low Dairy Habitual Diet<br>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<br>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)<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dairy, Diet, Inflammation, postprandial