Actively Recruiting
Effects of Physical Exercise and a Nutritional Supplement on Body Composition, Metabolic Function, and Overall Health in Adults With a Metabolically Challenging Profile
Led by University of Valencia · Updated on 2026-05-04
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of physical exercise combined with a nutritional supplement on body composition, metabolic function, and overall health in adults aged 50 to 65 years who have metabolic challenges but are not clinically obese. The study focuses on adults with overweight BMI (25.0 to 29.9 kg/m²) who exhibit mild metabolic dysfunction, such as altered body fat, abnormal glucose or lipid markers, or low physical activity. This trial aims to identify targeted interventions for this growing population at increased cardiometabolic risk despite non-obese BMI status. The study is a 12-week randomized, controlled, triple-blind clinical trial with two parallel groups. One group receives a multicomponent functional exercise program combined with a daily oral thermogenic and appetite-modulating nutritional supplement called phenylcapsaicin. The other group receives the same exercise program and a placebo supplement identical in appearance but without the active ingredient. Both groups follow a standardized dietary control plan to isolate the supplement's specific effects. Participants will attend supervised exercise sessions three times per week, each lasting 60 minutes, featuring joint mobility, strength, coordination, and agility exercises. Before and after the 12-week intervention, researchers will assess body composition using dual-energy X-ray absorptiometry (DXA), metabolic and hormonal biomarkers, aerobic and strength capacity, and quality of life, sleep, and appetite through validated questionnaires. These measures will help evaluate changes in fat distribution, metabolic function, and overall health in this metabolically challenged adult population.
CONDITIONS
Brief Title
Effects of Physical Exercise and a Nutritional Supplement on Body Composition, Metabolic Function, and Overall Health in Adults With a Metabolically Challenging Profile
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 65 years at screening
- BMI between 25.0 and 29.9 kg/m² (overweight, not obese)
- Presence of at least two metabolic risk factors: body fat ≥30% in women or ≥25% in men, or borderline fasting glucose, triglycerides, HDL or LDL cholesterol levels, or low physical activity (≤600 MET·min/week)
- Clinically stable without acute illness
- Able to perform moderate exercise three times per week
- No structured exercise programs (≥2 days/week) in previous 6 months
- No intensive calorie-restricted diets or medical weight-loss treatments in previous 3 months
- Ability to understand study and provide signed informed consent
You will not qualify if you...
- BMI ≥30.0 kg/m² (obesity) or weight-related conditions contraindicating participation
- Diagnosis of type 1 or type 2 diabetes mellitus
- Moderate or severe cardiovascular, renal, hepatic, or respiratory disease
- Neurological or musculoskeletal disorders limiting exercise
- Current or recent (within 3 months) use of weight-loss drugs, corticosteroids, thyroid hormones (non-replacement), anabolic agents, or body composition-affecting drugs
- Use of capsaicin, phenylcapsaicin, or similar supplements in last 3 months
- Cognitive, psychiatric, or mental health disorders impairing study compliance
- Physical limitations preventing safe exercise
- High-risk alcohol consumption (>20 g/day)
- Heavy smoking (>10 cigarettes/day) unless clinically stable
- Participation in another clinical trial
- Any other condition posing extra risk or interfering with study outcomes as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants undergo a 12-week intervention involving supervised multicomponent functional exercise sessions three times per week combined with either a thermogenic and appetite-modulating nutritional supplement or a placebo supplement. Participants follow a standardized dietary control plan throughout the intervention.
3 exercise sessions per week and daily supplement intake
Trial Site Locations
Total: 1 location
1
Physical activity and Sport Science Faculty
Valencia, Valencia, Spain, 46010
Actively Recruiting
Research Team
J
Juan Carlos Colado Sánchez, Chair full professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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