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Clinical Trial Summary

This study aims to produce new evidence, specific to women, on the efficacy and mechanisms of exercise and diet for cardiometabolic risk reduction in pre and postmenopausal women. Using a 3-arm randomized controlled trial (RCT) with equal recruitment and stratification by menopausal status to 6 months of: 1) exercise following Health Canada guidelines; 2) the same exercise plus counselling to follow Canada's Dietary Guidelines to improve diet quality; or 3) stretching group, this study will answer the following questions: - How does the impact of exercise compare among each of the causal links between physical inactivity and cardiometabolic disease in women? - What is the effect modification of adding a diet quality intervention to exercise? - What is the effect modification by menopausal status? The investigators hypothesize that exercise adaptations will be: 1) largest peripherally, including Matsuda index (primary outcome), Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), arteriovenous oxygen difference (avO2diff), and visceral fat, compared to centrally (stroke volume (SV), endothelial function, aortic stiffness), 2) blunted or absent in post vs premenopause; 3) enhanced by the addition of diet quality which will be essential or additive for Matsuda index, metabolic syndrome, Framingham cardiovascular disease (CVD) risk, cytokines and adipokines, thigh myosteatosis, muscle mass, peak oxygen uptake (VO2peak), 4) enhanced by adding diet quality in more outcomes postmenopause.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06345937
Study type Interventional
Source University of Toronto
Contact Amy A. Kirkham, PhD
Phone 416-946-4069
Email amy.kirkham@utoronto.ca
Status Recruiting
Phase N/A
Start date May 3, 2024
Completion date August 1, 2028

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