Metabolic SyndromeNCT07015307
Sustainable Exercise and Nutrition Programs for Managing Metabolic Disorders in Older Women
A study testing Sustainable Diet Program, Supervised Physical Exercise Program and Combined Sustainable Diet and Exercise Program in people with Metabolic Syndrome and Aging, run by University of Alicante at 1 site in Spain.
Trial summary
This study aims to evaluate the impact of sustainable diet and exercise programs on metabolic health and quality of life in older women. Participants will be assigned to different intervention groups including supervised physical training, personalized dietary guidance based on the Mediterranean dietary pattern, or a… Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Aging, Sarcopenia
- What is being tested?
- Sustainable Diet Program, Supervised Physical Exercise Program and Combined Sustainable Diet and Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2025to 31 Dec 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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Female participants aged 65 years or older
- Ability to walk independently or with assistive device
- Capacity to provide informed consent
- For groups with metabolic alterations: clinical diagnosis of metabolic syndrome based on standard criteria
- For healthy volunteers: absence of diagnosed metabolic or cardiovascular disease
Who cannot join
- Diagnosed cognitive impairment or dementia
- Unstable cardiovascular, respiratory, or musculoskeletal condition
- Participation in another structured lifestyle intervention during the study
- Any medical contraindication for physical exercise
- Severe mobility limitation preventing safe participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study and Design of New Sustainable Exercise and Dietary-nutritional Programs for the Treatment of Metabolic Disorders in Elderly Women
This study aims to evaluate the impact of sustainable diet and exercise programs on metabolic health and quality of life in older women. Participants will be assigned to different intervention groups including supervised physical training, personalized dietary guidance based on the Mediterranean dietary pattern, or a combination of both. The programs will be implemented over several weeks, with continuous monitoring of variables such as body composition, functional capacity, strength, fatigue perception, sleep quality, and emotional well-being. The project also includes the development of a digital platform to support remote engagement and long-term health behavior change.
Read the detailed description
This is a multi-phase interventional study designed to evaluate the impact of sustainable dietary and physical activity programs on metabolic health, functional capacity, and quality of life in older women. The target population includes women aged 65 and older, both with and without metabolic alterations.
The study comprises three phases:
Phase 1 includes initial assessments and an observational comparison between healthy older women and those with metabolic alterations.
Phase 2 implements three 12-week intervention programs: (1) a sustainable dietary strategy based on the Mediterranean diet, (2) a structured physical exercise program (both supervised and unsupervised), and (3) a combined intervention integrating both diet and exercise. Participants are assigned to groups based on their health status and intervention type.
Phase 3 focuses on knowledge transfer through the development of practical guidelines and a digital platform to facilitate remote monitoring and promote long-term adherence to healthy behaviors.
Primary and secondary outcomes include anthropometric measurements, body composition, handgrip strength, lower limb strength, walking speed, cardiovascular endurance, basal metabolic rate, blood pressure, blood biomarkers (glucose, cholesterol, triglycerides), fatigue perception, sleep quality, stress levels, emotional well-being, and health-related quality of life. Validated tools such as indirect calorimetry, digital hand dynamometers, functional capacity tests, and the SF-36 questionnaire will be employed.
The results are expected to support the design of sustainable, non-pharmacological strategies for the prevention and management of metabolic disorders and functional decline in aging women.
- Conditions
- Metabolic Syndrome, Aging, Sarcopenia, Obesity, Chronic Disease, Frailty
- Being tested
- Sustainable Diet Program, Supervised Physical Exercise Program, Combined Sustainable Diet and Exercise Program
- Keywords
- Mediterranean diet, Functional training, Women over 65, Lifestyle intervention, Nutrition and exercise
- Medical subject headings
- Metabolic Syndrome, Sarcopenia, Obesity, Chronic Disease, Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustainable Diet ProgramBehavioural
Intervention based on the Mediterranean sustainable diet. It emphasizes the consumption of fish, fruits, and vegetables, while reducing the intake of meat and meat-derived products. The diet is tailored to the participants' health status, activity level, and nutritional requirements, following the recommendations of the Spanish Society of Cardiology and Endocrinology. Macronutrient and micronutrient goals follow national guidelines and are tracked using specialized dietary software.
Supervised Physical Exercise ProgramBehavioural
A 12-week supervised physical exercise program led by certified professionals in Sport Sciences. Exercise prescriptions are tailored individually based on baseline assessments and international guidelines from fields such as cardiology and metabolism. The sessions may include strength, endurance, or combined training. In the supervised period, the instructor guides the sessions, while during the unsupervised period, exercises are followed via an online platform that provides detailed explanations and graphics.
Combined Sustainable Diet and Exercise ProgramBehavioural
This experimental arm combines the dietary intervention based on the sustainable Mediterranean diet with the structured physical exercise program. Both components are personalized and adhere to national and international health and nutrition recommendations. The program includes a 12-week supervised phase and an unsupervised online phase, aiming to maximize improvements in metabolic, physical, and psychosocial health in older women with metabolic alterations.
| Study group | Role | What they receive |
|---|---|---|
| Control - Healthy Women | No intervention | Women over 65 years of age with no diagnosed metabolic alterations. Participants will follow their usual lifestyle without any specific nutritional or physical exercise intervention |
| Control - Metabolic Alterations | No intervention | Women over 65 years of age with metabolic alterations. Participants will continue their habitual routines without intervention, serving as a control group for comparison with the intervention arms. |
| Diet Intervention | Experimental | Women with metabolic alterations will follow a sustainable dietary intervention based on Mediterranean principles. Personalized meal plans and regular follow-up will be delivered over a 12-week period. The aim is to improve metabolic and inflammatory markers. Receives: Behavioral: Sustainable Diet Program |
| Exercise Intervention | Experimental | Participants will perform a supervised physical exercise program focused on strength and functional training over 12 weeks. Exercises will be tailored to the participants' physical condition and delivered through structured sessions. Receives: Behavioral: Supervised Physical Exercise Program |
| Combined Diet + Exercise | Experimental | Participants will follow both the sustainable diet and the exercise program over a 12-week intervention period. This group will help assess the potential synergistic effect of the combined lifestyle strategies. Receives: Behavioral: Combined Sustainable Diet and Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured in kilograms using a calibrated digital scale.
Measured: Baseline (Week 0) and Week 12
Heigth
Measured in centimeters using a fixed wall-mounted stadiometer.
Measured: Baseline (Week 0) and Week 12
BMI
Calculated as weight (kg) divided by height squared (m²), using measurements taken as above.
Measured: Baseline (Week 0) and Week 12
Waist circunference
Measured in centimeters using a flexible, non-elastic anthropometric tape at the midpoint between the last rib and the iliac crest.
Measured: Baseline (Week 0) and Week 12
Body fat percentage
Measured using multifrequency bioelectrical impedance.
Measured: Baseline (Week 0) and Week 12
Health-related quality of life (SF-36 score)
Measured using the 36-Item Short Form Health Survey (SF-36), validated in Spanish (Vilagut, 2005), which assesses 8 domains of quality of life. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: Baseline (Week 0) and Week 12
Fatigue and perceived effort
Measured with the Fatigue Severity Scale (FSS), a validated questionnaire that includes 9 items rated on a 7-point Likert scale. Scores range from 1 to 7, with higher scores indicating greater fatigue and perceived effort.
Measured: Baseline (Week 0) and Week 12
Energy intake (kcal/day)
Total daily energy intake assessed through 3-day dietary records and a validated food frequency questionnaire for the Spanish population. Energy intake will be calculated in kilocalories per day (kcal/day) using standardized nutrient databases.
Measured: Baseline (Week 0) and Week 12
Carbohydrate intake
Average daily carbohydrate intake measured through 3-day dietary records, expressed in grams. Higher values indicate greater carbohydrate consumption.
Measured: Baseline (Week 0) and Week 12
Protein intake
Average daily protein intake measured through 3-day dietary records, expressed in grams. Higher values indicate greater protein consumption.
Measured: Baseline (Week 0) and Week 12
Fat intake
Average daily fat intake measured through 3-day dietary records, expressed in grams. Higher values indicate greater fat consumption.
Measured: Baseline (Week 0) and Week 12
Daily step count
Average number of steps per day measured with an accelerometer-based activity tracker. Higher scores indicate higher physical activity levels.
Measured: Baseline (Week 0) and Week 12
Active minutes per day
Daily time spent in moderate to vigorous physical activity, measured in minutes per day using an accelerometer. Higher scores indicate higher physical activity levels.
Measured: Baseline (Week 0) and Week 12
Sedentary time per day
Average number of minutes per day spent in sedentary behavior (e.g., sitting or lying down), measured via accelerometer. Higher scores indicate greater sedentary behavior (worse outcome).
Measured: Baseline (Week 0) and Week 12
Sleep quality (PSQI total score)
Measured using the Pittsburgh Sleep Quality Index (PSQI), which provides a global score based on 19 items grouped into 7 components. Total scores range from 0 to 21, where higher scores indicate poorer sleep quality. PSQI score (range: 0-21).
Measured: Baseline (Week 0) and Week 12
Gait speed (10-meter walk test)
Assessed by measuring the time to walk 10 meters at usual pace using infrared photocells (Chronojump, Barcelona, Spain).
Measured: Baseline (Week 0) and Week 12
Cardiovascular endurance (6-minute walk test)
Evaluated using the 6-minute walk test (6MWT). Distance walked in 6 minutes on a flat surface, timed with a chronometer. Conducted on the athletics track at the University of Alicante.
Measured: Baseline (Week 0) and Week 12
Handgrip strength
Measured using a digital hand dynamometer. Maximum isometric voluntary contraction recorded in the dominant hand.
Measured: Baseline (Week 0) and Week 12
Lower-limb isometric strength
Assessed through maximum isometric voluntary contraction of the lower limbs using Kinvent force sensors and biofeedback platform.
Measured: Baseline (Week 0) and Week 12
Sarcopenia diagnosis
Assessed according to the European Working Group on Sarcopenia in Older People criteria (EWGSOP, Cruz-Jentoft et al., 2010), using muscle strength, muscle mass and functional performance.
Measured: Baseline (Week 0) and Week 12
Basal metabolic rate
Measured using indirect calorimetry
Measured: Baseline (Week 0) and Week 12
Systolic and diastolic blood pressure
Assessed using an automatic digital sphygmomanometer (Omron Healthcare, Osaka, Japan), following standardized measurement protocol.
Measured: Baseline (Week 0) and Week 12
Cholesterol
Measured using the Accutrend Plus analyzer (Roche Diagnostic, Mannheim, Germany) from capillary blood samples.
Measured: Baseline (Week 0) and Week 12
Triglycerides
Measured using the Accutrend Plus analyzer (Roche Diagnostic, Mannheim, Germany) from capillary blood samples.
Measured: Baseline (Week 0) and Week 12
Glucose
Measured using the Accutrend Plus analyzer (Roche Diagnostic, Mannheim, Germany) from capillary blood samples.
Measured: Baseline (Week 0) and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jun 2025
- Primary completion30 Sep 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to parallel intervention groups (dietary strategy, physical exercise, or combined). No crossover will occur between arms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante
- Investigators
- Alejandro Martínez Rodríguez, Dr., Principal investigator, Alicante University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015307
- Sponsor's protocol ID
- UA-2025-05-19_1
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study and Design of New Sustainable Exercise and Dietary-nutritional Programs for the Treatment of Metabolic Disorders in Elderly Women
- ClinicalTrials.gov ID
- NCT07015307
- Acronym / sponsor ID
- UA-2025-05-19_1
- Conditions
- Metabolic Syndrome, Aging, Sarcopenia, Obesity, Chronic Disease, Frailty
- Keywords
- Mediterranean diet, Functional training, Women over 65, Lifestyle intervention, Nutrition and exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jun 2025 (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.
This study aims to evaluate the impact of sustainable diet and exercise programs on metabolic health and quality of life in older women. Participants will be assigned to different intervention groups including supervised physical training, personalized dietary guidance based on the Mediterranean dietary pattern, or a combination of both. The programs will be implemented over several weeks, with continuous monitoring of variables such as body composition, functional capacity, strength, fatigue perception, sleep quality, and emotional well-being. The project also includes the development of a digital platform to support remote engagement and long-term health behavior change.
Detailed description
This is a multi-phase interventional study designed to evaluate the impact of sustainable dietary and physical activity programs on metabolic health, functional capacity, and quality of life in older women. The target population includes women aged 65 and older, both with and without metabolic alterations.
The study comprises three phases:
Phase 1 includes initial assessments and an observational comparison between healthy older women and those with metabolic alterations.
Phase 2 implements three 12-week intervention programs: (1) a sustainable dietary strategy based on the Mediterranean diet, (2) a structured physical exercise program (both supervised and unsupervised), and (3) a combined intervention integrating both diet and exercise. Participants are assigned to groups based on their health status and intervention type.
Phase 3 focuses on knowledge transfer through the development of practical guidelines and a digital platform to facilitate remote monitoring and promote long-term adherence to healthy behaviors.
Primary and secondary outcomes include anthropometric measurements, body composition, handgrip strength, lower limb strength, walking speed, cardiovascular endurance, basal metabolic rate, blood pressure, blood biomarkers (glucose, cholesterol, triglycerides), fatigue perception, sleep quality, stress levels, emotional well-being, and health-related quality of life. Validated tools such as indirect calorimetry, digital hand dynamometers, functional capacity tests, and the SF-36 questionnaire will be employed.
The results are expected to support the design of sustainable, non-pharmacological strategies for the prevention and management of metabolic disorders and functional decline in aging women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- Participants will be randomly assigned to parallel intervention groups (dietary strategy, physical exercise, or combined). No crossover will occur between arms.
| Arm | Type | Receives |
|---|---|---|
| Control - Healthy Women | No intervention | –Women over 65 years of age with no diagnosed metabolic alterations. Participants will follow their usual lifestyle without any specific nutritional or physical exercise intervention |
| Control - Metabolic Alterations | No intervention | –Women over 65 years of age with metabolic alterations. Participants will continue their habitual routines without intervention, serving as a control group for comparison with the intervention arms. |
| Diet Intervention | Experimental | Behavioral: Sustainable Diet ProgramWomen with metabolic alterations will follow a sustainable dietary intervention based on Mediterranean principles. Personalized meal plans and regular follow-up will be delivered over a 12-week period. The aim is to improve metabolic and inflammatory markers. |
| Exercise Intervention | Experimental | Behavioral: Supervised Physical Exercise ProgramParticipants will perform a supervised physical exercise program focused on strength and functional training over 12 weeks. Exercises will be tailored to the participants' physical condition and delivered through structured sessions. |
| Combined Diet + Exercise | Experimental | Behavioral: Combined Sustainable Diet and Exercise ProgramParticipants will follow both the sustainable diet and the exercise program over a 12-week intervention period. This group will help assess the potential synergistic effect of the combined lifestyle strategies. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Female participants aged 65 years or older
- Ability to walk independently or with assistive device
- Capacity to provide informed consent
- For groups with metabolic alterations: clinical diagnosis of metabolic syndrome based on standard criteria
- For healthy volunteers: absence of diagnosed metabolic or cardiovascular disease
Key exclusion criteria (5 listed)
- Diagnosed cognitive impairment or dementia
- Unstable cardiovascular, respiratory, or musculoskeletal condition
- Participation in another structured lifestyle intervention during the study
- Any medical contraindication for physical exercise
- Severe mobility limitation preventing safe participation
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 |
|---|---|---|
| Sustainable Diet ProgramIntervention based on the Mediterranean sustainable diet. It emphasizes the consumption of fish, fruits, and vegetables, while reducing the intake of meat and meat-derived products. The diet is tailored to the participants' health status, activity level, and nutritional requirements, following the recommendations of the Spanish Society of Cardiology and Endocrinology. Macronutrient and micronutrient goals follow national guidelines and are tracked using specialized dietary software. | Behavioural | Diet Intervention |
| Supervised Physical Exercise ProgramA 12-week supervised physical exercise program led by certified professionals in Sport Sciences. Exercise prescriptions are tailored individually based on baseline assessments and international guidelines from fields such as cardiology and metabolism. The sessions may include strength, endurance, or combined training. In the supervised period, the instructor guides the sessions, while during the unsupervised period, exercises are followed via an online platform that provides detailed explanations and graphics. | Behavioural | Exercise Intervention |
| Combined Sustainable Diet and Exercise ProgramThis experimental arm combines the dietary intervention based on the sustainable Mediterranean diet with the structured physical exercise program. Both components are personalized and adhere to national and international health and nutrition recommendations. The program includes a 12-week supervised phase and an unsupervised online phase, aiming to maximize improvements in metabolic, physical, and psychosocial health in older women with metabolic alterations. | Behavioural | Combined Diet + Exercise |
Primary outcome
Weight
Time frame: Baseline (Week 0) and Week 12
Measured in kilograms using a calibrated digital scale.
Heigth
Time frame: Baseline (Week 0) and Week 12
Measured in centimeters using a fixed wall-mounted stadiometer.
BMI
Time frame: Baseline (Week 0) and Week 12
Calculated as weight (kg) divided by height squared (m²), using measurements taken as above.
Waist circunference
Time frame: Baseline (Week 0) and Week 12
Measured in centimeters using a flexible, non-elastic anthropometric tape at the midpoint between the last rib and the iliac crest.
Body fat percentage
Time frame: Baseline (Week 0) and Week 12
Measured using multifrequency bioelectrical impedance.
Health-related quality of life (SF-36 score)
Time frame: Baseline (Week 0) and Week 12
Measured using the 36-Item Short Form Health Survey (SF-36), validated in Spanish (Vilagut, 2005), which assesses 8 domains of quality of life. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Fatigue and perceived effort
Time frame: Baseline (Week 0) and Week 12
Measured with the Fatigue Severity Scale (FSS), a validated questionnaire that includes 9 items rated on a 7-point Likert scale. Scores range from 1 to 7, with higher scores indicating greater fatigue and perceived effort.
Energy intake (kcal/day)
Time frame: Baseline (Week 0) and Week 12
Total daily energy intake assessed through 3-day dietary records and a validated food frequency questionnaire for the Spanish population. Energy intake will be calculated in kilocalories per day (kcal/day) using standardized nutrient databases.
Carbohydrate intake
Time frame: Baseline (Week 0) and Week 12
Average daily carbohydrate intake measured through 3-day dietary records, expressed in grams. Higher values indicate greater carbohydrate consumption.
Protein intake
Time frame: Baseline (Week 0) and Week 12
Average daily protein intake measured through 3-day dietary records, expressed in grams. Higher values indicate greater protein consumption.
Fat intake
Time frame: Baseline (Week 0) and Week 12
Average daily fat intake measured through 3-day dietary records, expressed in grams. Higher values indicate greater fat consumption.
Daily step count
Time frame: Baseline (Week 0) and Week 12
Average number of steps per day measured with an accelerometer-based activity tracker. Higher scores indicate higher physical activity levels.
Active minutes per day
Time frame: Baseline (Week 0) and Week 12
Daily time spent in moderate to vigorous physical activity, measured in minutes per day using an accelerometer. Higher scores indicate higher physical activity levels.
Sedentary time per day
Time frame: Baseline (Week 0) and Week 12
Average number of minutes per day spent in sedentary behavior (e.g., sitting or lying down), measured via accelerometer. Higher scores indicate greater sedentary behavior (worse outcome).
Sleep quality (PSQI total score)
Time frame: Baseline (Week 0) and Week 12
Measured using the Pittsburgh Sleep Quality Index (PSQI), which provides a global score based on 19 items grouped into 7 components. Total scores range from 0 to 21, where higher scores indicate poorer sleep quality. PSQI score (range: 0-21).
Gait speed (10-meter walk test)
Time frame: Baseline (Week 0) and Week 12
Assessed by measuring the time to walk 10 meters at usual pace using infrared photocells (Chronojump, Barcelona, Spain).
Cardiovascular endurance (6-minute walk test)
Time frame: Baseline (Week 0) and Week 12
Evaluated using the 6-minute walk test (6MWT). Distance walked in 6 minutes on a flat surface, timed with a chronometer. Conducted on the athletics track at the University of Alicante.
Handgrip strength
Time frame: Baseline (Week 0) and Week 12
Measured using a digital hand dynamometer. Maximum isometric voluntary contraction recorded in the dominant hand.
Lower-limb isometric strength
Time frame: Baseline (Week 0) and Week 12
Assessed through maximum isometric voluntary contraction of the lower limbs using Kinvent force sensors and biofeedback platform.
Sarcopenia diagnosis
Time frame: Baseline (Week 0) and Week 12
Assessed according to the European Working Group on Sarcopenia in Older People criteria (EWGSOP, Cruz-Jentoft et al., 2010), using muscle strength, muscle mass and functional performance.
Basal metabolic rate
Time frame: Baseline (Week 0) and Week 12
Measured using indirect calorimetry
Systolic and diastolic blood pressure
Time frame: Baseline (Week 0) and Week 12
Assessed using an automatic digital sphygmomanometer (Omron Healthcare, Osaka, Japan), following standardized measurement protocol.
Cholesterol
Time frame: Baseline (Week 0) and Week 12
Measured using the Accutrend Plus analyzer (Roche Diagnostic, Mannheim, Germany) from capillary blood samples.
Triglycerides
Time frame: Baseline (Week 0) and Week 12
Measured using the Accutrend Plus analyzer (Roche Diagnostic, Mannheim, Germany) from capillary blood samples.
Glucose
Time frame: Baseline (Week 0) and Week 12
Measured using the Accutrend Plus analyzer (Roche Diagnostic, Mannheim, Germany) from capillary blood samples.
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 5 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Alejandro Martínez Rodríguez, Dr. principal investigator
Alicante University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sustainable Diet Program, Supervised Physical Exercise Program and Combined Sustainable Diet and Exercise Program in people with Metabolic Syndrome and Aging, run by University of Alicante 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?
The sponsor lists 5 inclusion and 5 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Baseline (Week 0) and Week 12). The study lists 25 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 5 Oct 2026.