Inflammation Clinical Trial
— DRIVEOfficial title:
Influence of Increased Dairy Product Consumption on Markers of Inflammation and Cardiometabolic Disease
Verified date | June 2024 |
Source | York University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | York University | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
York University | Dairy Farmers of Canada |
Canada,
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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