Exercise and Diet for Metabolic Disorders

(MsFIT Trial)

Overseen By Jenna B. Gillen, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Toronto

Must not be taking: Weight loss medications, Exogenous hormones

Disqualifiers: Cardiovascular diseases, Diabetes, Cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

180 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking weight loss medications, you may not be eligible to participate.

What data supports the effectiveness of the treatment involving exercise and diet for metabolic disorders?

Research shows that following Canada's physical activity guidelines can significantly reduce the risk of chronic diseases like heart disease, type 2 diabetes, and hypertension. Regular physical activity, as recommended, is linked to lower rates of these conditions and can help prevent premature death. ^{1 2 3 4 5}

Is the exercise and diet treatment generally safe for humans?

The research suggests that following Canada's physical activity and dietary guidelines is generally safe and can reduce the risk of many chronic conditions, such as heart disease, stroke, and diabetes, without significant safety concerns. ^{1 2 3 6 7}

How does the treatment 'Exercise and Diet for Metabolic Disorders' differ from other treatments for metabolic disorders?

This treatment is unique because it combines guidelines-based physical activity and healthy eating, following Health Canada guidelines, to address metabolic disorders. Unlike medications, it focuses on lifestyle changes that can prevent and manage a wide range of chronic conditions, such as heart disease and diabetes, by promoting moderate-intensity exercise and a balanced diet. ^{1 2 3 4 8}

Research Team

Amy A Kirkham, PhD

Principal Investigator

University of Toronto

Eligibility Criteria

This trial is for pre and postmenopausal women who are dealing with metabolic disorders due to a sedentary lifestyle. Participants should be interested in improving their health through physical activity and possibly dietary changes.

Inclusion Criteria

High CANRISK score (score of ≥33) as determined by the online CANRISK tool

I can visit the University weekly for 6 months.

I am either before or after menopause.

Exclusion Criteria

My BMI is over 40.

Exceeding self-reported moderate-to-vigorous intensity aerobic physical activity

Diagnosed history of an eating disorder or self-report of potential undiagnosed eating disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to one of three groups: exercise following Health Canada guidelines, exercise plus dietary counseling, or a stretching group for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3-6 months

Treatment Details

Interventions

• Guidelines-based physical activity
• Guidelines-based physical activity and healthy eating
• Stretching exercise

Trial Overview The study tests three approaches: 1) exercise following Health Canada guidelines, 2) the same exercise plus healthy eating advice, or 3) just stretching exercises. It aims to see how these affect heart and metabolic health differently before and after menopause.

Participant Groups

Group I: Guidelines-based physical activity and healthy eating Experimental Treatment 1 Intervention

150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening + counselling to follow Canada's Food Guide

Group II: Guidelines-based physical activity Experimental Treatment 1 Intervention

150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening

Group III: Stretching exercise Placebo Group 1 Intervention

Whole-body stretching

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

The systematic review of 254 studies confirms a clear dose-response relationship between physical activity and reduced risk of seven chronic diseases, including cardiovascular disease and type 2 diabetes, as well as lower premature all-cause mortality.

The findings support that Canada's Physical Activity Guide for Healthy Active Living is effective in promoting physical activity levels that can significantly reduce the risk of these chronic conditions and improve overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the evidence for Canada's Physical Activity Guidelines for Adults. Warburton, DE., Charlesworth, S., Ivey, A., et al.[2023]

Regular moderate-intensity physical activity, as recommended by Canadian and international guidelines, can significantly reduce the risk of over 25 chronic conditions, including heart disease, stroke, and certain cancers.

If the Canadian population adhered to these physical activity guidelines, it is estimated that a substantial number of deaths from chronic diseases could be prevented, highlighting the critical role of physical activity in public health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-informed physical activity guidelines for Canadian adults. Warburton, DE., Katzmarzyk, PT., Rhodes, RE., et al.[2018]

Regular moderate-intensity physical activity, as recommended by Canadian and international guidelines, can significantly reduce the risk of over 25 chronic conditions, including heart disease, stroke, and certain cancers.

If the Canadian population adhered to these physical activity guidelines, it is estimated that a substantial number of deaths from chronic diseases could be prevented, highlighting the critical role of physical activity in public health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evidence-based guidelines for physical activity of adult Canadians]. Warburton, DE., Katzmarzyk, PT., Rhodes, RE., et al.[2016]

Canadian adults who meet the physical activity guidelines have significantly lower odds of developing chronic diseases such as type 2 diabetes, obesity, and hypertension compared to those who do not meet these guidelines.

The study found that higher leisure-time energy expenditure (LTEE) is associated with reduced odds of chronic conditions, with notable differences in health outcomes between the lowest and highest quartiles of LTEE for both sexes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between meeting physical activity guidelines and chronic diseases among Canadian adults. Bryan, SN., Katzmarzyk, PT.[2022]

This review clarifies the current physical activity guidelines for health and weight management, addressing confusion among health professionals about which guidelines to apply for different populations.

It emphasizes the importance of understanding these guidelines in clinical practice, particularly for helping overweight and sedentary individuals overcome barriers to physical activity and when to refer them to exercise scientists for additional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interpreting the physical activity guidelines for health and weight management. Andersen, RE., Jakicic, JM.[2019]

The 2019 Canadian guideline for physical activity during pregnancy was rated as high quality (83%) based on a thorough appraisal using the AGREE II instrument, indicating it is a reliable resource for promoting health in pregnant individuals.

The guideline includes six key recommendations and safety precautions for clinicians, aimed at effectively integrating these evidence-based practices into patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity throughout pregnancy: guideline critical appraisal and implementation tool. Connell, G., Weis, CA., Hollman, H., et al.[2022]

A survey of 6,536 adults in Manitoba found that 69.5% met the minimum physical activity requirements set by Canada's Physical Activity Guide to Healthy Active Living (CPAG), indicating a positive trend in activity levels compared to previous surveys.

However, only 29.1% of respondents achieved these levels through vigorous activity, suggesting that while many are active, the intensity of their activities may not be sufficient to combat rising obesity and chronic disease rates, prompting a recommendation to review CPAG guidelines to better include daily living activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canada's physical activity guide recommendations are a low benchmark for Manitoba adults. Ready, AE., Butcher, JE., Dear, JB., et al.[2016]

This systematic review aims to evaluate the quality of physical activity and exercise guidelines aimed at preventing cardiometabolic diseases, analyzing documents published from 2000 to October 2019.

The review will utilize the Appraisal of Guidelines for Research and Evaluation II tool to assess the quality of these guidelines, which will help improve future recommendations for promoting physical activity in healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines about physical activity and exercise to reduce cardiometabolic risk factors: protocol for a systematic review and critical appraisal. Siedler, M., Murad, MH., Falck-Ytter, Y., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

A systematic review of the evidence for Canada's Physical Activity Guidelines for Adults. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Evidence-informed physical activity guidelines for Canadian adults. [2018]

3. Canada pubmed.ncbi.nlm.nih.gov

[Evidence-based guidelines for physical activity of adult Canadians]. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

The association between meeting physical activity guidelines and chronic diseases among Canadian adults. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Interpreting the physical activity guidelines for health and weight management. [2019]

6. Canada pubmed.ncbi.nlm.nih.gov

Physical activity throughout pregnancy: guideline critical appraisal and implementation tool. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Canada's physical activity guide recommendations are a low benchmark for Manitoba adults. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Guidelines about physical activity and exercise to reduce cardiometabolic risk factors: protocol for a systematic review and critical appraisal. [2023]