Sustainable Exercise and Nutrition Programs for Managing Metabolic Disorders in Older Women

University of Alicante

Status: Active, not recruiting

Conditions: Aging; Chronic Disease; Obesity; Frailty; Sarcopenia; Metabolic Syndrome

Treatments: Behavioral: Sustainable Diet Program; Behavioral: Combined Sustainable Diet and Exercise Program; Behavioral: Supervised Physical Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07015307

UA-2025-05-19_1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 5 patient groups

Control - Healthy Women

No Intervention group

Description:

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 group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Sustainable Diet Program

Exercise Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Supervised Physical Exercise Program

Combined Diet + Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Combined Sustainable Diet and Exercise Program