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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04902417
Other study ID # 2021-177
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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