Sustainable Exercise and Nutrition Programs for Managing Metabolic Disorders in Older Women
NCT ID: NCT07015307
Last Updated: 2025-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
140 participants
INTERVENTIONAL
2025-06-01
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control - Healthy Women
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
No interventions assigned to this group
Control - Metabolic Alterations
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.
No interventions assigned to this group
Diet Intervention
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.
Sustainable Diet Program
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.
Exercise Intervention
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.
Supervised Physical Exercise Program
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 Diet + Exercise
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.
Combined Sustainable Diet and Exercise Program
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.
Interventions
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Sustainable Diet Program
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 Program
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 Program
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
65 Years
FEMALE
Yes
Sponsors
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University of Alicante
OTHER
Responsible Party
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Prof. Dr. Alejandro Martínez-Rodríguez
Alejandro Martínez-Rodríguez
Principal Investigators
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Alejandro Martínez Rodríguez, Dr.
Role: PRINCIPAL_INVESTIGATOR
Alicante University
Locations
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European Institute Of Exercise and Health
Elche, Alicante, Spain
Countries
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Other Identifiers
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UA-2025-05-19_1
Identifier Type: -
Identifier Source: org_study_id
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