Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345937
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-03-28
Brief Title:
Multiple Risk Factor Intervention Trial Ms FIT
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
Multiple Risk Factor Intervention Trial Ms FIT
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MsFIT
Brief 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 Canadas 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None