AgingNCT07504068
Effects of Physical Exercise and a Nutritional Supplement on Body Composition, Metabolic Function, and Overall Health in Adults With a Metabolically Challenging Profile
A study testing Group 1: Exercise + thermogenic supplement (EX-TS) in people with Aging and Adults With Overweight and Obesity, run by University of Valencia at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Aging, Adults With Overweight and Obesity, Supplementation
- What is being tested?
- Group 1: Exercise + thermogenic supplement (EX-TS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 25 Mar 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion 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:
- Altered body composition (primary criterion): Body fat percentage ≥ 30% in women or ≥ 25% in men, assessed by DXA.
- 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
- 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.
Exclusion Criteria: 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 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Physical activity and Sport Science Faculty
Valencia, Valencia, 46010
Juan Carlos Colado Sánchez, Chair full professor, juan.colado@uv.es
Juan Carlos Colado Sánchez, Chair full professor
About this study
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.
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-obese BMI (Stefan, 2020). This profile is associated with increased insulin resistance, low-grade systemic inflammation, and elevated cardiovascular risk, underscoring the need for targeted interventions in "metabolically challenged" individuals. Xiong et al. (2024) demonstrated that metabolic health status independently predicts cardiovascular risk, even when BMI is within non-obese ranges. This evidence supports the rationale of the present project: to intervene in a group of adults without clinical obesity (BMI < 30 kg/m²) but presenting at least two indicators of mild metabolic dysfunction.
Read more
Nutritional supplements with thermogenic properties that promote fat oxidation and satiety-such as phenylcapsaicin, an analog of capsaicin designed to improve bioavailability and reduce pungency, thereby enhancing tolerability in adults-may offer a promising complementary strategy. Recent studies have shown that low doses of phenylcapsaicin were sufficient to increase fat oxidation during exercise, reduce respiratory exchange ratio, and lower maximal heart rate during submaximal testing compared with placebo (Jiménez-Martínez et al., 2023a). Furthermore, additional research reported that phenylcapsaicin improved strength performance, reduced perceived exertion, and attenuated markers of muscle damage following resistance training (Jiménez-Martínez et al., 2023b). These findings suggest that thermogenic and fat-oxidation-enhancing supplementation may act as a safe and effective metabolic modulator, particularly when combined with exercise, positioning it as an innovative strategy for adults presenting mild metabolic risk.
The present study would integrate: (1) a multicomponent functional exercise program designed to improve strength, balance, and aerobic capacity in older adults; (2) a thermogenic and fat-oxidation-enhancing nutritional supplement as a safe metabolic activation strategy; (3) a standardized dietary control protocol to isolate the specific effects of the supplementation; (4) dual-energy X-ray absorptiometry (DXA) for precise body composition assessment; (5) hormonal and lipid biomarkers to evaluate underlying physiological mechanisms; and (6) validated questionnaires addressing quality of life, sleep, and appetite to capture the holistic dimension of this stage of adulthood.
This multidimensional approach would provide an innovative intervention for a growing yet underexplored population: non-obese but metabolically challenged adults at increasing cardiometabolic risk.
References:
- Jiménez-Martínez P, Sánchez-Valdepeñas J, Cornejo-Daza PJ, Cano-Castillo C, Asín-Izquierdo I, Alix-Fages C, Pareja-Blanco F, Colado JC. Effects of different phenylcapsaicin doses on neuromuscular activity and mechanical performance in trained male subjects: a randomized, triple-blinded, crossover, placebo-controlled trial. Front Physiol. 2023a Aug 2; 14: 1215644.
- Jiménez-Martínez P, Cornejo-Daza PJ, Sánchez-Valdepeñas J, Asín-Izquierdo I, Cano-Castillo C, Alix-Fages C, Pareja-Blanco F, Colado JC. Effects of different phenylcapsaicin doses on resistance training performance, muscle damage, protein breakdown, metabolic response, ratings of perceived exertion, and recovery: a randomized, triple-blinded, placebo-controlled, crossover trial. J Int Soc Sports Nutr. 2023b Dec; 20 (1): 2204083.
- Stefan N. Metabolically healthy and unhealthy normal weight and obesity. Endocrinol Metab (Seoul). 2020 Sep;35(3):487-493.
- Xiong Q, Zang Y, Li J, An Y, and Yu S. Comparison of cardiovascular disease risk association with metabolic unhealthy obesity identified by body fat percentage and body mass index: Results from the 1999-2020 National Health and Nutrition Examination Survey. PLoS One. 2024 Aug 14; 19 (8): e0305592.
- Wu Y, Li D, and Vermund SH. Advantages and limitations of the body mass index (BMI) to assess adult obesity. Int J Environ Res Public Health. 2024 Jun 10; 21 (6): 757.
Read the detailed description
The present project is designed as a longitudinal, randomized, controlled, parallel-group, triple-blind clinical trial, with a 12-week active intervention and pre- and post-intervention assessments.
The study will be conducted at a single center (single-center trial) and will include two parallel groups:
- Experimental group: multicomponent functional exercise + thermogenic and appetite-modulating nutritional supplement.
- Control group: multicomponent functional exercise + placebo supplement (identical in appearance, without active ingredient).
Randomization will be performed using balanced block allocation, stratified by sex and baseline body fat percentage, with a 1:1 allocation ratio.
The study will be triple-blind:
- Participants,
- The intervention and assessment team,
- And the statistician responsible for data analysis will remain unaware of group allocation (experimental or control).
The design corresponds to a comparative efficacy trial aimed at evaluating the additional effect of the nutritional supplement compared to placebo, while maintaining identical exercise programming and dietary control in both groups. This approach allows isolation of the specific impact of the supplement on body composition, metabolic function, functional capacity, and perceived health in adults with a metabolically challenged profile but without clinical obesity.
As is standard practice, participants will be informed that their allocation may correspond to either the placebo or experimental group, without disclosure of their actual assignment.
As appropriate in experimental studies, standardized collection of biological samples and psychometric and perceived health data will be conducted at pre- and post-intervention time points to quantify changes in these metrics and analyze them as dependent variables of the applied protocol.
- Conditions
- Aging, Adults With Overweight and Obesity, Supplementation, Exercise
- Being tested
- Group 1: Exercise + thermogenic supplement (EX-TS), Group 2: Exercise + placebo supplement (EX-PL)
- Keywords
- Older adults, Adults with metabolic disorders, Nutritional supplement, Multicomponent exercise, Healthy aging, Quality of life, Non-pharmacological intervention, Randomized controlled trial
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: Exercise + thermogenic supplement (EX-TS)Dietary supplement
Participants in this group will receive an oral daily dose of the nutritional supplement with thermogenic and appetite-modulating effects in combination with a supervised multicomponent functional program (3 sessions per week, 60 minutes each) for 12 weeks, composed by three exercise blocks: 1) joint mobility and postural control exercises block, 2) functional strength block with three sets of two strength exercises using elastic bands at 70%-85 of 1RM (RPE 6-7 at the beginning and 9 at the end of the set) and, 3) coordination and agility exercises block. Participants will undergo a standardized dietary control plan based on Individualized energy deficit equivalent to 0.7% of body weight per week, adjusted using the Harris-Benedict equation, and macronutrient distribution: protein: 2 g/kg; fat: 0.8 g/kg; remaining energy intake allocated to carbohydrates.
Group 2: Exercise + placebo supplement (EX-PL)Dietary supplement
Participants in this group will receive a placebo supplement identical in appearance, color and taste to the active supplement, together with the same multicomponent functional exercise program and dietary control for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Exercise + thermogenic supplement (EX-TS) | Experimental | Participants in this group will receive an oral daily dose of the nutritional supplement with thermogenic and appetite-modulating effects in combination with a supervised multicomponent functional exercise program (3 sessions per week, 60 minutes each) for 12 weeks Receives: Dietary Supplement: Group 1: Exercise + thermogenic supplement (EX-TS) |
| Group 2: Exercise + placebo supplement (EX-PL) | Placebo comparator | Participants in this group will receive a placebo supplement identical in appearance, color and taste to the active supplement, together with the same multicomponent functional exercise program for 12 weeks Receives: Dietary Supplement: Group 2: Exercise + placebo supplement (EX-PL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body composition via Dual-Energy X-ray Absorptiometry (DXA)
Whole body and segmental composition will be assessed through Dual-Energy X-ray Absorptiometry (DXA). Parameters analyzed will be: total and regional fat mass and lean mass
Measured: Pre and post-intervention of 12 weeks
Change in fat distribution via Dual-Energy X-ray Absorptiometry (DXA)
Android/gynoid fat distribution will be analyzed through Dual-Energy X-ray Absorptiometry (DXA).
Measured: Pre and post-intervention of 12 weeks
Change in hormonal biomarkers (glucagon-like peptide-1;GLP-1)
glucagon-like peptide-1 (GLP-1) will be collected through a blood sample in the morning in a fasted state to assess hormonal state
Measured: Pre and post-intervention of 12 weeks
Change in hormonal biomarkers (acylated ghrelin)
Acylated ghrelin levels will be collected through a blood sample in the morning in a fasted state to assess hormonal state
Measured: Pre and post-intervention of 12 weeks
Change in hormonal biomarkers (leptin)
Leptin levels will be collected through a blood sample in the morning in a fasted state to assess hormonal state
Measured: Pre and post-intervention of 12 weeks
Change in metabolic biomarkers (glucose)
Glucose levels will be collected through a blood sample in the morning in a fasted state to assess metabolic state.
Measured: Pre and post-intervention of 12 weeks
Change in metabolic biomarkers (total cholesterol)
Total cholesterol levels will be collected through a blood sample in the morning in a fasted state to assess metabolic state.
Measured: Pre and post-intervention of 12 weeks
Change in metabolic biomarkers (HDL cholesterol)
HDL cholesterol levels will be collected through a blood sample in the morning in a fasted state to assess metabolic state.
Measured: Pre and post-intervention of 12 weeks
Change in metabolic biomarkers (LDL cholesterol)
LDL cholesterol levels will be collected through a blood sample in the morning in a fasted state to assess metabolic state.
Measured: Pre and post-intervention of 12 weeks
Change in metabolic biomarkers (triglycerides)
Triglycerides levels will be collected through a blood sample in the morning in a fasted state to assess metabolic state.
Measured: Pre and post-intervention of 12 weeks
Change in metabolic biomarkers (creatine)
Creatinine levels will be collected through a blood sample in the morning in a fasted state to assess metabolic state.
Measured: Pre and post-intervention of 12 weeks
Change in metabolic biomarkers (aspartate aminotransferase; ATS)
AST (Aspartate aminotransferase) levels will be collected through a blood sample in the morning in a fasted state to assess metabolic state.
Measured: Pre and post-intervention of 12 weeks
Secondary outcomes (15)
Change in body composition via bioelectrical impedance analysis (BIA)
Whole body fat-free mass will be assessed through bioelectrical impedance analysis (BIA)
Measured: Pre and post-intervention of 12 weeks
Changes in distance covered/aerobic capacity
Distance covered/aerobic capacity will be assessed through the 6- Minute walking test
Measured: Pre and post-intervention of 12 weeks
Changes in lower limb strength
Lower limb strength will be assessed through the 30-second Chair Stand Test
Measured: Pre and post-intervention of 12 weeks
Changes in agility and dynamic balance
Agility and dynamic balance will be assessed through the Timed Up and Go Test
Measured: Pre and post-intervention of 12 weeks
Changes in handgrip strength
Handgrip strength will be assessed through the Handgrip dynamometry (Jamar Hand Dynamometer).
Measured: Pre and post-intervention of 12 weeks
Changes in quality of life specific for older adults
Quality of life will be assessed through the World Health Organization Quality of Life-OLD (WHOQOL-OLD) questionnaire
Measured: Pre and post-intervention of 12 weeks
Changes in general quality of life
Quality of life will be assessed through the Short Form-36 Health Survey (SF-36) questionnaire
Measured: Pre and post-intervention of 12 weeks
Changes in general health perception
General health perception will be assessed through the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) questionnaire
Measured: Pre and post-intervention of 12 weeks
Change in sleep quality
Sleep quality will be assessed through Pittsburgh Sleep Quality Index
Measured: Pre and post-intervention of 12 weeks
Change in perceived insomnia
Perceived insomnia will be assessed through the Insomnia Severity Index
Measured: Pre and post-intervention of 12 weeks
Change in eating behavior
Eating behavior will be assessed through the Emotional Eater Questionnaire
Measured: Pre and post-intervention of 12 weeks
Change in appetite behavior
Appetite behavior will be assessed through the Simplified Nutritional Appetite Questionnaire
Measured: Pre and post-intervention of 12 weeks
Anthropometric changes (waist and hip circumferences)
Waist circumference and hip circumference will be measured
Measured: Pre and post-intervention of 12 weeks
Anthropometric changes (waist -hip index)
waist -hip index will be measured
Measured: Pre and post-intervention of 12 weeks
Anthropometric changes (waist to height index)
waist to height index will be measured
Measured: Pre and post-intervention of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start25 Mar 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan C. Colado, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504068
- Sponsor's protocol ID
- 2025-FIS-4275027
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 2025-FIS-4275027
- Conditions
- Aging, Adults With Overweight and Obesity, Supplementation, Exercise
- Keywords
- Older adults, Adults with metabolic disorders, Nutritional supplement, Multicomponent exercise, Healthy aging, Quality of life, Non-pharmacological intervention, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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-obese BMI (Stefan, 2020). This profile is associated with increased insulin resistance, low-grade systemic inflammation, and elevated cardiovascular risk, underscoring the need for targeted interventions in "metabolically challenged" individuals. Xiong et al. (2024) demonstrated that metabolic health status independently predicts cardiovascular risk, even when BMI is within non-obese ranges. This evidence supports the rationale of the present project: to intervene in a group of adults without clinical obesity (BMI < 30 kg/m²) but presenting at least two indicators of mild metabolic dysfunction.
Nutritional supplements with thermogenic properties that promote fat oxidation and satiety-such as phenylcapsaicin, an analog of capsaicin designed to improve bioavailability and reduce pungency, thereby enhancing tolerability in adults-may offer a promising complementary strategy. Recent studies have shown that low doses of phenylcapsaicin were sufficient to increase fat oxidation during exercise, reduce respiratory exchange ratio, and lower maximal heart rate during submaximal testing compared with placebo (Jiménez-Martínez et al., 2023a). Furthermore, additional research reported that phenylcapsaicin improved strength performance, reduced perceived exertion, and attenuated markers of muscle damage following resistance training (Jiménez-Martínez et al., 2023b). These findings suggest that thermogenic and fat-oxidation-enhancing supplementation may act as a safe and effective metabolic modulator, particularly when combined with exercise, positioning it as an innovative strategy for adults presenting mild metabolic risk.
The present study would integrate: (1) a multicomponent functional exercise program designed to improve strength, balance, and aerobic capacity in older adults; (2) a thermogenic and fat-oxidation-enhancing nutritional supplement as a safe metabolic activation strategy; (3) a standardized dietary control protocol to isolate the specific effects of the supplementation; (4) dual-energy X-ray absorptiometry (DXA) for precise body composition assessment; (5) hormonal and lipid biomarkers to evaluate underlying physiological mechanisms; and (6) validated questionnaires addressing quality of life, sleep, and appetite to capture the holistic dimension of this stage of adulthood.
This multidimensional approach would provide an innovative intervention for a growing yet underexplored population: non-obese but metabolically challenged adults at increasing cardiometabolic risk.
References:
- Jiménez-Martínez P, Sánchez-Valdepeñas J, Cornejo-Daza PJ, Cano-Castillo C, Asín-Izquierdo I, Alix-Fages C, Pareja-Blanco F, Colado JC. Effects of different phenylcapsaicin doses on neuromuscular activity and mechanical performance in trained male subjects: a randomized, triple-blinded, crossover, placebo-controlled trial. Front Physiol. 2023a Aug 2; 14: 1215644.
- Jiménez-Martínez P, Cornejo-Daza PJ, Sánchez-Valdepeñas J, Asín-Izquierdo I, Cano-Castillo C, Alix-Fages C, Pareja-Blanco F, Colado JC. Effects of different phenylcapsaicin doses on resistance training performance, muscle damage, protein breakdown, metabolic response, ratings of perceived exertion, and recovery: a randomized, triple-blinded, placebo-controlled, crossover trial. J Int Soc Sports Nutr. 2023b Dec; 20 (1): 2204083.
- Stefan N. Metabolically healthy and unhealthy normal weight and obesity. Endocrinol Metab (Seoul). 2020 Sep;35(3):487-493.
- Xiong Q, Zang Y, Li J, An Y, and Yu S. Comparison of cardiovascular disease risk association with metabolic unhealthy obesity identified by body fat percentage and body mass index: Results from the 1999-2020 National Health and Nutrition Examination Survey. PLoS One. 2024 Aug 14; 19 (8): e0305592.
- Wu Y, Li D, and Vermund SH. Advantages and limitations of the body mass index (BMI) to assess adult obesity. Int J Environ Res Public Health. 2024 Jun 10; 21 (6): 757.
Detailed description
The present project is designed as a longitudinal, randomized, controlled, parallel-group, triple-blind clinical trial, with a 12-week active intervention and pre- and post-intervention assessments.
The study will be conducted at a single center (single-center trial) and will include two parallel groups:
- Experimental group: multicomponent functional exercise + thermogenic and appetite-modulating nutritional supplement.
- Control group: multicomponent functional exercise + placebo supplement (identical in appearance, without active ingredient).
Randomization will be performed using balanced block allocation, stratified by sex and baseline body fat percentage, with a 1:1 allocation ratio.
The study will be triple-blind:
- Participants,
- The intervention and assessment team,
- And the statistician responsible for data analysis will remain unaware of group allocation (experimental or control).
The design corresponds to a comparative efficacy trial aimed at evaluating the additional effect of the nutritional supplement compared to placebo, while maintaining identical exercise programming and dietary control in both groups. This approach allows isolation of the specific impact of the supplement on body composition, metabolic function, functional capacity, and perceived health in adults with a metabolically challenged profile but without clinical obesity.
As is standard practice, participants will be informed that their allocation may correspond to either the placebo or experimental group, without disclosure of their actual assignment.
As appropriate in experimental studies, standardized collection of biological samples and psychometric and perceived health data will be conducted at pre- and post-intervention time points to quantify changes in these metrics and analyze them as dependent variables of the applied protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Exercise + thermogenic supplement (EX-TS) | Experimental | Dietary Supplement: Group 1: Exercise + thermogenic supplement (EX-TS)Participants in this group will receive an oral daily dose of the nutritional supplement with thermogenic and appetite-modulating effects in combination with a supervised multicomponent functional exercise program (3 sessions per week, 60 minutes each) for 12 weeks |
| Group 2: Exercise + placebo supplement (EX-PL) | Placebo comparator | Dietary Supplement: Group 2: Exercise + placebo supplement (EX-PL)Participants in this group will receive a placebo supplement identical in appearance, color and taste to the active supplement, together with the same multicomponent functional exercise program for 12 weeks |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1: Exercise + thermogenic supplement (EX-TS)Participants in this group will receive an oral daily dose of the nutritional supplement with thermogenic and appetite-modulating effects in combination with a supervised multicomponent functional program (3 sessions per week, 60 minutes each) for 12 weeks, composed by three exercise blocks: 1) joint mobility and postural control exercises block, 2) functional strength block with three sets of two strength exercises using elastic bands at 70%-85 of 1RM (RPE 6-7 at the beginning and 9 at the end of the set) and, 3) coordination and agility exercises block. Participants will undergo a standardized dietary control plan based on Individualized energy deficit equivalent to 0.7% of body weight per week, adjusted using the Harris-Benedict equation, and macronutrient distribution: protein: 2 g/kg; fat: 0.8 g/kg; remaining energy intake allocated to carbohydrates. | Dietary supplement | Group 1: Exercise + thermogenic supplement (EX-TS) |
| Group 2: Exercise + placebo supplement (EX-PL)Participants in this group will receive a placebo supplement identical in appearance, color and taste to the active supplement, together with the same multicomponent functional exercise program and dietary control for 12 weeks. | Dietary supplement | Group 2: Exercise + placebo supplement (EX-PL) |
Primary outcome
Change in body composition via Dual-Energy X-ray Absorptiometry (DXA)
Time frame: Pre and post-intervention of 12 weeks
Whole body and segmental composition will be assessed through Dual-Energy X-ray Absorptiometry (DXA). Parameters analyzed will be: total and regional fat mass and lean mass
Change in fat distribution via Dual-Energy X-ray Absorptiometry (DXA)
Time frame: Pre and post-intervention of 12 weeks
Android/gynoid fat distribution will be analyzed through Dual-Energy X-ray Absorptiometry (DXA).
Change in hormonal biomarkers (glucagon-like peptide-1;GLP-1)
Time frame: Pre and post-intervention of 12 weeks
glucagon-like peptide-1 (GLP-1) will be collected through a blood sample in the morning in a fasted state to assess hormonal state
Change in hormonal biomarkers (acylated ghrelin)
Time frame: Pre and post-intervention of 12 weeks
Acylated ghrelin levels will be collected through a blood sample in the morning in a fasted state to assess hormonal state
Change in hormonal biomarkers (leptin)
Time frame: Pre and post-intervention of 12 weeks
Leptin levels will be collected through a blood sample in the morning in a fasted state to assess hormonal state
Change in metabolic biomarkers (glucose)
Time frame: Pre and post-intervention of 12 weeks
Glucose levels will be collected through a blood sample in the morning in a fasted state to assess metabolic state.
Change in metabolic biomarkers (total cholesterol)
Time frame: Pre and post-intervention of 12 weeks
Total cholesterol levels will be collected through a blood sample in the morning in a fasted state to assess metabolic state.
Change in metabolic biomarkers (HDL cholesterol)
Time frame: Pre and post-intervention of 12 weeks
HDL cholesterol levels will be collected through a blood sample in the morning in a fasted state to assess metabolic state.
Change in metabolic biomarkers (LDL cholesterol)
Time frame: Pre and post-intervention of 12 weeks
LDL cholesterol levels will be collected through a blood sample in the morning in a fasted state to assess metabolic state.
Change in metabolic biomarkers (triglycerides)
Time frame: Pre and post-intervention of 12 weeks
Triglycerides levels will be collected through a blood sample in the morning in a fasted state to assess metabolic state.
Change in metabolic biomarkers (creatine)
Time frame: Pre and post-intervention of 12 weeks
Creatinine levels will be collected through a blood sample in the morning in a fasted state to assess metabolic state.
Change in metabolic biomarkers (aspartate aminotransferase; ATS)
Time frame: Pre and post-intervention of 12 weeks
AST (Aspartate aminotransferase) levels will be collected through a blood sample in the morning in a fasted state to assess metabolic state.
15 secondary outcomes
Change in body composition via bioelectrical impedance analysis (BIA)
Time frame: Pre and post-intervention of 12 weeks
Changes in distance covered/aerobic capacity
Time frame: Pre and post-intervention of 12 weeks
Changes in lower limb strength
Time frame: Pre and post-intervention of 12 weeks
Changes in agility and dynamic balance
Time frame: Pre and post-intervention of 12 weeks
Changes in handgrip strength
Time frame: Pre and post-intervention of 12 weeks
Changes in quality of life specific for older adults
Time frame: Pre and post-intervention of 12 weeks
Changes in general quality of life
Time frame: Pre and post-intervention of 12 weeks
Changes in general health perception
Time frame: Pre and post-intervention of 12 weeks
Change in sleep quality
Time frame: Pre and post-intervention of 12 weeks
Change in perceived insomnia
Time frame: Pre and post-intervention of 12 weeks
Change in eating behavior
Time frame: Pre and post-intervention of 12 weeks
Change in appetite behavior
Time frame: Pre and post-intervention of 12 weeks
Anthropometric changes (waist and hip circumferences)
Time frame: Pre and post-intervention of 12 weeks
Anthropometric changes (waist -hip index)
Time frame: Pre and post-intervention of 12 weeks
Anthropometric changes (waist to height index)
Time frame: Pre and post-intervention of 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: Exercise + thermogenic supplement (EX-TS) in people with Aging and Adults With Overweight and Obesity, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Carlos Colado Sánchez, Chair full professor ((9639) 83470, juan.colado@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body composition via Dual-Energy X-ray Absorptiometry (DXA) (time frame: Pre and post-intervention of 12 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.