York University
Toronto, Ontario, M3J 1P3, Canada
NCT Number: NCT04902417
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Toronto, Ontario, M3J 1P3, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: pre-intervention
Concentration of Interleukin-6
Time frame: immediately after the 6 week intervention
Concentration of Interleukin-6
Time frame: 1 hour post meal
Concentration of Interleukin-6
Time frame: 2 hour post meal
Concentration of Interleukin-6
Time frame: 3 hour post meal
Concentration of Interleukin-6
Time frame: 4 hour post meal
Concentration of Interleukin-6
Time frame: 5 hour post meal
Concentration of Interleukin-6
Time frame: pre-intervention
Concentration of serum cholesterol
Time frame: immediately after the 6 week intervention
Concentration of serum cholesterol
Time frame: pre-intervention
Concentration of serum triglycerides
Time frame: immediately after the 6 week intervention
Concentration of serum triglycerides
Time frame: pre-intervention
Concentration of blood glucose
Time frame: immediately after the 6 week intervention
Concentration of blood glucose
Time frame: pre-intervention
Concentration of blood insulin
Time frame: immediately after the 6 week intervention
Concentration of blood insulin
Time frame: pre-intervention
flow-mediated dilation (FMD)
Time frame: immediately after the 6 week intervention
flow-mediated dilation (FMD)
Time frame: pre-intervention
fat mass (kg)
Time frame: immediately after the 6 week intervention
fat mass (kg)
York University
Other
Influence of Increased Dairy Product Consumption on Markers of Inflammation and Cardiometabolic Disease
Acronym: DRIVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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