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Study identifier: NCT06345937 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Multiple Risk Factor Intervention Trial (Ms. FIT)

Condition: Metabolic Disturbance · Sedentary Behavior  ·  Sponsor: University of Toronto

PhaseNA
Planned participants180
Who can joinFemale, 30 Years to no upper limit
Healthy volunteersNo

About this study

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 outcom…

This description comes directly from the study's public registry record.

Talk to the study team

Amy A. Kirkham, PhD  ·  416-946-4069  ·  amy.kirkham@utoronto.ca

Jenna B. Gillen, PhD  ·  416-978-3244  ·  jenna.gillen@utoronto.ca

Always discuss trial participation with your own doctor first.

Locations (1)

University of TorontoToronto, Ontario, CanadaRecruiting

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Source record: clinicaltrials.gov/study/NCT06345937