Smart diet and exercise coaching may tame metabolic syndrome
NCT ID NCT07535333
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding exercise-focused lifestyle coaching to a personalized diet plan improves health in 435 overweight or obese adults with metabolic syndrome. Participants will either follow a diet plan alone or a diet plan plus an intelligent lifestyle program that targets exercise capacity. The goal is to see if the combined approach reduces the number of people with metabolic syndrome and improves fitness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dietary prescription (Mediterranean or DASH diet) combined with exercise capacity-targeted intelligent lifestyle management
- What this could lead to
- If successful, this could show that combining personalized diet with exercise coaching is more effective than diet alone for managing metabolic syndrome.
- What could go wrong
- This is an early-stage behavioral study with no drug intervention, so results may be modest. Participants must follow complex lifestyle changes, and adherence may vary.
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 435 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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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20 to 60 years
- Sex
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Anyone
- 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: * Aged between 20 and 60 years. * Overweight or obese, with a Body Mass Index (BMI) ≥ 24 kg/m² and \< 40 kg/m². * Patients with impaired metabolic parameters regarding glucose, lipids, and blood pressure,meet at least two of the following criteria: * Central obesity: Waist circumference ≥ 90 cm for males or ≥ 85 cm for females. * Hyperglycemia: Fasting plasma glucose (FPG) ≥ 6.1 mmol/L, or 2-hour plasma glucose ≥ 7.8 mmol/L during an oral glucose tolerance test (OGTT), and/or currently receiving treatment for previously diagnosed diabetes. * Hypertension: Blood pressure ≥ 130/85 mmHg, and/or currently receiving treatment for previously diagnosed hypertension. * Elevated fasting triglycerides (TG): ≥ 1.7 mmol/L. * Reduced fasting high-density lipoprotein cholesterol (HDL-C): \< 1.04 mmol/L. Exclusion Criteria: * History of cardiovascular or cerebrovascular disease, or in the acute phase, including: angina pectoris, myocardial infarction, coronary revascularization surgery, stroke (ischemic or hemorrhagic, including transient ischemic attack), symptomatic peripheral artery disease requiring surgery or diagnosed via angiographic techniques, ventricular arrhythmias, uncontrolled atrial fibrillation, congestive heart failure (New York Heart Association class III or IV), hypertrophic cardiomyopathy, history of aneurysm with diameter ≥ 5.5 cm, or history of aneurysm surgery. * Malignancy or history of malignancy within the past five years. * Religious restrictions or dysphagia preventing adherence to the recommended diet. * Contraindications to exercise, such as orthopedic disorders. * Participation in other weight-loss programs (\> 5 kg weight loss) within the six months prior to the screening visit. * History of bariatric surgery or intention to undergo bariatric surgery within the next 12 months. * History of small or large bowel resection or inflammatory bowel disease. * Obesity due to endocrine disorders of unknown cause (excluding treated hypothyroidism). * Allergy to any food components of the Mediterranean diet. * Immunodeficiency or HIV positive status. * Cirrhosis or liver failure. * Severe psychiatric disorders, including schizophrenia, bipolar disorder, eating disorders, or depression requiring hospitalization in the past 6 months. Severe comorbidities with a life expectancy of less than 24 months. * Alcoholism, addiction, or drug abuse in the past six months (or daily alcohol consumption \> 50 g). * History of major organ transplantation. * Concomitant use of immunosuppressive or cytotoxic medications. * Current use of systemic corticosteroids. * Current use of weight-loss medications. * Currently participating in another randomized clinical trial. * Patients with acute infection or inflammation (e.g., pneumonia) may -participate 3 months after resolution of the condition. * Pregnant or planning to become pregnant during the study period. * Any other condition that may interfere with protocol compliance. * Refusal to sign the informed consent document.
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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 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.
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