Can exercise and diet cut heart risk in women? new study aims to find out
NCT ID NCT06345937
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study looks at how exercise and healthy eating affect heart and metabolic health in women with multiple risk factors. Researchers will follow 180 pre- and postmenopausal women for 6 months, comparing exercise alone, exercise plus diet advice, and a stretching group. The goal is to understand how these lifestyle changes improve insulin resistance and other heart risk markers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- exercise and dietary counselling
- What this could lead to
- If successful, this could show how exercise and diet specifically benefit women's heart health, leading to better prevention guidelines for women.
- What could go wrong
- This is a small, early-stage study (180 participants) that measures risk factors, not actual disease outcomes. Results may not apply to all women or lead to immediate treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Biologically female * Aged 30+ * Pre- or postmenopausal: Premenopause: having regular menstrual cycles (21-35 days long without a persistent difference of ≥7 days between cycles). Post-menopause: ≥12 months of amenorrhea or history of double oophorectomy and do not have irregular or occasional menstrual cycle in last 12 months. * Participants will have multiple risk factors for cardiometabolic disease, namely: being sedentary (\<30 min of moderate-vigorous physical activity/week), having a BMI ≥ 25 kg/m\^2, and one or more of the following: a waist circumference indicative of abdominal obesity, specific to BMI (e.g., BMI 25-29.9: WC: ≥90cm; BMI 30-34.9: WC: ≥105cm; BMI 35-35.9: WC: ≥115cm) OR a diagnosis of either hypertension, pre-diabetes (heightened blood sugar levels), or dyslipidemia (heightened blood lipid levels) * Able to commit to come to the University once per week for 24 weeks. Exclusion Criteria: * Perimenopausal or those whom the investigators cannot discern pre- vs perimenopausal status * Diagnosed cardiovascular diseases, type 2 diabetes, non-alcoholic fatty liver disease, cancer (except for non-melanoma skin cancer), or respiratory disease (e.g., Chronic obstructive pulmonary disease (COPD) or severe or uncontrolled asthma). * Major signs or symptoms of cardiovascular diseases, diabetes, or renal disease (taken from the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription 11th edition Table 2.1: pain or discomfort in the chest, neck, jaw, arms with rest or exercise, shortness of breath at rest or with mild exertion, dizziness or syncope, loss of balance or passing out, ankle edema, palpitations or tachycardia, intermittent claudication, known heart murmur, unusual fatigue with usual activities.) * American Heart Association's absolute or relative contraindications for symptom-limited maximal exercise testing (myocardial infarction, aortic or coronary artery stenosis, heart failure, pulmonary embolism or deep vein thrombosis, inflammation of the heart (myocarditis, pericarditis, and/or endocarditis), uncontrolled cardiac arrythmia, advanced or complete electrical heart block, stroke or transient ischemia attack, blood pressure \>200mmHg/100mmHg, a cancer diagnosis other than skin cancer) * Unable to provide informed consent or communicate in English * Pregnant or breast-feeding currently or in the past 3 months * Mobility limitations to aerobic exercise (i.e., wheelchair, walker use, limp impeding walking) * Smoking cigarettes or marijuana within the past 3 months * Taking exogenous hormones in any format currently or in the past 3 months * Contraindications to research MRI (e.g., pacemaker, magnetic implants) * BMI exceeding 40 kg/m2 * Extreme claustrophobia * Self-report \>30 min/week of moderate-to-vigorous intensity aerobic physical activity * Following a diet that largely restricts entire food groups or time of eating (e.g., vegan, ketogenic, carnivore, one meal a day) in last 3 months * Students in classes or labs of the professors who are involved in the study * Experienced significant weight loss (i.e., \>5 kg) in past 3 months * Currently taking weight loss medications * Diagnosed history of an eating disorder or self-report of potential undiagnosed eating disorder * Plans to be away/unavailable for a substantial period of the intervention overall (i.e., \>4 weeks throughout the 6 months or \>2 weeks within the first 12 weeks of the intervention). * Allergies to local anesthetics
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Toronto
RECRUITINGToronto, Ontario, M5S 2C9, Canada
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