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New treatment option for Aging
Official title Effects of Physical Exercise and a Nutritional Supplement on Body Composition, Metabolic Function, and Overall Health in Adults With a Metabolically Challenging Profile
ClinicalTrials.gov ID: NCT07504068
What this study is testing
- What it's testing
- 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).
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 65
You may be able to join if
- Individuals will be eligible to participate in the study if they meet all of the following criteria:
- Age: Between 50 and 65 years at the time of screening.
- Weight status (non-obese): Body mass index (BMI) between 25.0 and 29.9 kg/m² (overweight range, without clinical obesity).
- Metabolically challenged profile (non-obese): Presence of at least two of the following criteria, in addition to the specified BMI range: A) Altered...
- Fasting glucose: 100-125 mg/dL
You likely can't join if
- Individuals presenting any of the following conditions will be excluded from the study:
- 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.
- Relevant or uncontrolled chronic diseases:
- Previous diagnosis of type 1 or type 2 diabetes mellitus.
See the full eligibility criteria
- Individuals will be eligible to participate in the study if they meet all of the following criteria:
- Age: Between 50 and 65 years at the time of screening.
- Weight status (non-obese): Body mass index (BMI) between 25.0 and 29.9 kg/m² (overweight range, without clinical obesity).
- 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...
- 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.
- 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.
- 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.
- Administrative and ethical aspects:
- Ability to understand study explanations and follow instructions.
- Signed informed consent prior to initiation of any study procedures.
- Individuals presenting any of the following conditions will be excluded from the study:
- 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.
- 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.
- 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
- Specific prior supplementation: Use of capsaicin, phenylcapsaicin, or other thermogenic or appetite-modulating supplements within the previous 3 months.
- 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.
- Substance use:
- Alcohol consumption at levels considered high risk (\> 20 g/day).
- Heavy smoking (\> 10 cigarettes/day), unless deemed clinically stable by the investigator.
- Other exclusion criteria:
- Concurrent participation in another clinical trial or treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Valencia, Valencia, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valencia, Valencia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.