Dairy and Inflammation Study

Inflammation Clinical Trial

— DRIVE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04902417
• Other study ID #: 2021-177
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2024
• Source: York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: December 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiometabolic Risk
• Inflammation
• Overweight
• Overweight and Obesity

Intervention

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

Locations

Country	Name	City	State
Canada	York University	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
York University	Dairy Farmers of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Inflammation	Concentration of Interleukin-6	pre-intervention
Primary	Fasting Inflammation	Concentration of Interleukin-6	immediately after the 6 week intervention
Primary	Postprandial Inflammation	Concentration of Interleukin-6	1 hour post meal
Primary	Postprandial Inflammation	Concentration of Interleukin-6	2 hour post meal
Primary	Postprandial Inflammation	Concentration of Interleukin-6	3 hour post meal
Primary	Postprandial Inflammation	Concentration of Interleukin-6	4 hour post meal
Primary	Postprandial Inflammation	Concentration of Interleukin-6	5 hour post meal
Secondary	Fasting Lipids	Concentration of serum cholesterol	pre-intervention
Secondary	Fasting Lipids	Concentration of serum cholesterol	immediately after the 6 week intervention
Secondary	Fasting Lipids	Concentration of serum triglycerides	pre-intervention
Secondary	Fasting Lipids	Concentration of serum triglycerides	immediately after the 6 week intervention
Secondary	Fasting glucose	Concentration of blood glucose	pre-intervention
Secondary	Fasting glucose	Concentration of blood glucose	immediately after the 6 week intervention
Secondary	Fasting insulin	Concentration of blood insulin	pre-intervention
Secondary	Fasting insulin	Concentration of blood insulin	immediately after the 6 week intervention
Secondary	vascular measures	flow-mediated dilation (FMD)	pre-intervention
Secondary	vascular measures	flow-mediated dilation (FMD)	immediately after the 6 week intervention
Secondary	Body composition	fat mass (kg)	pre-intervention
Secondary	Body composition	fat mass (kg)	immediately after the 6 week intervention