Exercise and supplement combo targets hidden metabolic risks in overweight adults
NCT ID NCT07504068
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a combination of physical exercise and a nutritional supplement (phenylcapsaicin) can improve body composition, metabolism, and overall health in adults aged 50-65 who are overweight but not obese. Participants must have at least two signs of mild metabolic issues, like high blood sugar or cholesterol. The goal is to find a safe, effective way to reduce cardiometabolic risk in this growing population.
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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 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jul 2026
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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50 to 65 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: Individuals will be eligible to participate in the study if they meet all of the following criteria: 1. Age: Between 50 and 65 years at the time of screening. 2. Weight status (non-obese): Body mass index (BMI) between 25.0 and 29.9 kg/m² (overweight range, without clinical obesity). 3. Metabolically challenged profile (non-obese): Presence of at least two of the following criteria, in addition to the specified BMI range: A) Altered body composition (primary criterion): Body fat percentage ≥ 30% in women or ≥ 25% in men, assessed by DXA. B) Borderline metabolic markers (one or more): * Fasting glucose: 100-125 mg/dL * Triglycerides: ≥ 150 mg/dL * HDL cholesterol: \< 50 mg/dL in women or \< 40 mg/dL in men * LDL cholesterol: ≥ 130 mg/dL C) Sedentary lifestyle: Low or very low physical activity level, defined as ≤ 600 MET·min/week according to the IPAQ questionnaire. 4. Clinical and functional status: * Clinically stable condition, without acute disease or recent decompensation. * Ability to perform moderate-intensity exercise three times per week, according to medical assessment. 5. Previous treatment and lifestyle: * No participation in structured exercise programs (≥ 2 days/week) during the previous 6 months. * No intensive hypocaloric diets or medical weight-loss treatments during the previous 3 months. 6. Administrative and ethical aspects: * Ability to understand study explanations and follow instructions. * Signed informed consent prior to initiation of any study procedures. Exclusion Criteria: Individuals presenting any of the following conditions will be excluded from the study: 1. Clinical obesity or anthropometric extremes: * BMI ≥ 30.0 kg/m² (obesity). * Any weight-related or clinical condition that, in the judgment of the principal investigator, contraindicates participation. 2. Relevant or uncontrolled chronic diseases: * Previous diagnosis of type 1 or type 2 diabetes mellitus. * Moderate or severe cardiovascular disease (e.g., ischemic heart disease, heart failure, uncontrolled clinically significant arrhythmias). * Moderate or severe renal, hepatic, or respiratory disease. * Neurological or musculoskeletal disorders limiting or contraindicating the prescribed exercise program. 3. Pharmacological treatments interfering with energy metabolism or body weight: Current use (or use within the previous 3 months) of: * Weight-loss medications or GLP-1 receptor agonists * Systemic corticosteroids at moderate or high doses * Thyroid hormones at non-replacement doses * Anabolic agents or other drugs significantly affecting body composition 4. Specific prior supplementation: Use of capsaicin, phenylcapsaicin, or other thermogenic or appetite-modulating supplements within the previous 3 months. 5. Functional or cognitive limitations: * Cognitive, psychiatric, or mental health disorders that may impair study comprehension or protocol adherence. * Physical limitations preventing safe participation in exercise. 6. Substance use: * Alcohol consumption at levels considered high risk (\> 20 g/day). * Heavy smoking (\> 10 cigarettes/day), unless deemed clinically stable by the investigator. 7. Other exclusion criteria: * Concurrent participation in another clinical trial or interventional study. * Any other condition that, in the judgment of the principal investigator, may pose additional risk to the participant or significantly interfere with study outcomes.
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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
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Contacts and locations
Locations
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Physical activity and Sport Science Faculty
RECRUITINGValencia, Valencia, 46010, Spain
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