💬In plain words
What the trial is, and whether it could suit you
Early-onset metabolic disturbances (such as mild hyperglycemia, subclinical dyslipidemia, excess body fat, and reduced functional capacity) represent one of the major public health challenges among middle-aged and older adults. Although body mass index (BMI) remains the primary clinical criterion for classifying excess weight, growing evidence indicates that BMI does not adequately discriminate cardiometabolic risk, particularly in individuals classified as overweight who present elevated body fat levels (Wu et al., 2024).
Several studies have identified altered metabolic phenotypes that do not meet the criteria for obesity, including the so-called "metabolically unhealthy normal weight" (MUNW) or "metabolically unhealthy non-obese" phenotypes. These individuals are characterized by excess body fat, central adiposity, and alterations in glucose and lipid metabolism despite having a non-
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.