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Exercise and supplement combo targets hidden metabolic risks in overweight adults

NCT ID NCT07504068

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

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

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

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

50 to 65 years

Sex

Anyone

Healthy volunteers

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

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.

Motor Activity Obesity obesity disorder

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Physical activity and Sport Science Faculty

    RECRUITING

    Valencia, Valencia, 46010, Spain

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