Clinical trial NCT07015307: Sustainable Exercise and Nutrition Programs for Managing Metabolic Disorders in Older Women
Official title: Study and Design of New Sustainable Exercise and Dietary-nutritional Programs for the Treatment of Metabolic Disorders in Elderly Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Aging
Sarcopenia
Obesity
Chronic Disease
Frailty
Keywords: Mediterranean diet
Functional training
Women over 65
Lifestyle intervention
Nutrition and exercise
Lead sponsor: University of Alicante
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 140
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to parallel intervention groups (dietary strategy, physical exercise, or combined). No crossover will occur between arms.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight
timeFrame: Baseline (Week 0) and Week 12
measure: Heigth
timeFrame: Baseline (Week 0) and Week 12
measure: BMI
timeFrame: Baseline (Week 0) and Week 12
measure: Waist circunference
timeFrame: Baseline (Week 0) and Week 12
measure: Body fat percentage
timeFrame: Baseline (Week 0) and Week 12
measure: Health-related quality of life (SF-36 score)
timeFrame: Baseline (Week 0) and Week 12
measure: Fatigue and perceived effort
timeFrame: Baseline (Week 0) and Week 12
measure: Energy intake (kcal/day)
timeFrame: Baseline (Week 0) and Week 12
measure: Carbohydrate intake
timeFrame: Baseline (Week 0) and Week 12
measure: Protein intake
timeFrame: Baseline (Week 0) and Week 12
measure: Fat intake
timeFrame: Baseline (Week 0) and Week 12
measure: Daily step count
timeFrame: Baseline (Week 0) and Week 12
measure: Active minutes per day
timeFrame: Baseline (Week 0) and Week 12
measure: Sedentary time per day
timeFrame: Baseline (Week 0) and Week 12
measure: Sleep quality (PSQI total score)
timeFrame: Baseline (Week 0) and Week 12
measure: Gait speed (10-meter walk test)
timeFrame: Baseline (Week 0) and Week 12
measure: Cardiovascular endurance (6-minute walk test)
timeFrame: Baseline (Week 0) and Week 12
measure: Handgrip strength
timeFrame: Baseline (Week 0) and Week 12
measure: Lower-limb isometric strength
timeFrame: Baseline (Week 0) and Week 12
measure: Sarcopenia diagnosis
timeFrame: Baseline (Week 0) and Week 12
measure: Basal metabolic rate
timeFrame: Baseline (Week 0) and Week 12
measure: Systolic and diastolic blood pressure
timeFrame: Baseline (Week 0) and Week 12
measure: Cholesterol
timeFrame: Baseline (Week 0) and Week 12
measure: Triglycerides
timeFrame: Baseline (Week 0) and Week 12
measure: Glucose
timeFrame: Baseline (Week 0) and Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: European Institute Of Exercise and Health
state: Alicante
Study officials:
affiliation: Alicante University
name: Alejandro Martínez Rodríguez, Dr.
role: PRINCIPAL_INVESTIGATOR
References: