Exercise plus a thermogenic nutritional supplement to improve body composition and metabolic health in middle-aged adults with high body fat

Effects of Physical Exercise and a Nutritional Supplement on Body Composition, Metabolic Function, and Overall Health in Adults With a Metabolically Challenging Profile.

This 12-week program will test whether adding a thermogenic, appetite‑modulating supplement to a multicomponent exercise plan helps 50–65-year-olds who are overweight with high body fat improve body composition and metabolic markers.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 50 Years to 65 Years
• Sex: All
• Sponsor: University of Valencia (Academic / other)
• Locations: 1 site (Valencia, Valencia)
• Trial ID: NCT07504068 on ClinicalTrials.gov

What this trial studies

This is a single-center, randomized, triple-blind, parallel-group trial with a 12-week active intervention and pre- and post-intervention assessments. All participants follow the same multicomponent functional exercise program while one group receives a thermogenic and appetite-modulating supplement and the other group receives an identical placebo. Randomization is 1:1 with balanced blocks stratified by sex and baseline body fat percentage to ensure comparable groups. Primary outcomes include changes in body composition by DXA, metabolic blood markers, functional capacity, and perceived health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50–65 with BMI 25.0–29.9 kg/m² who have elevated body fat (≥30% for women, ≥25% for men) plus at least one borderline metabolic marker or a low physical activity level.

Not a fit: People with BMI under 25 or BMI ≥30 (clinical obesity), uncontrolled chronic illnesses, or those already highly physically active are unlikely to benefit from or be eligible for this intervention.

Why it matters

Potential benefit: If successful, the combined approach could reduce excess body fat, improve blood glucose and lipid measures, and enhance functional capacity in overweight middle-aged adults without clinical obesity.

How similar studies have performed: Previous trials of multicomponent exercise and various nutritional supplements have shown improvements in body composition and metabolic markers, but combining a thermogenic, appetite-modulating supplement with exercise in a triple-blind RCT for non-obese metabolically challenged adults is relatively novel.

Eligibility criteria

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.

Where this trial is running

Valencia, Valencia

• Physical activity and Sport Science Faculty — Valencia, Valencia, Spain (Recruiting)

Study contacts

• Study coordinator: Juan Carlos Colado Sánchez, Chair full professor

Conditions Aging; Adults With Overweight and Obesity; Supplementation; Exercise; Older adults; Adults with metabolic disorders; Nutritional supplement; Multicomponent exercise