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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
140
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.
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.
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.
European Institute Of Exercise and Health
Elche, Alicante, Spain
Weight
Measured in kilograms using a calibrated digital scale.
Time frame: Baseline (Week 0) and Week 12
Heigth
Measured in centimeters using a fixed wall-mounted stadiometer.
Time frame: Baseline (Week 0) and Week 12
BMI
Calculated as weight (kg) divided by height squared (m²), using measurements taken as above.
Time frame: 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.
Time frame: Baseline (Week 0) and Week 12
Body fat percentage
Measured using multifrequency bioelectrical impedance.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline (Week 0) and Week 12
Handgrip strength
Measured using a digital hand dynamometer. Maximum isometric voluntary contraction recorded in the dominant hand.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Week 0) and Week 12
Basal metabolic rate
Measured using indirect calorimetry
Time frame: 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.
Time frame: Baseline (Week 0) and Week 12
Cholesterol
Measured using the Accutrend Plus analyzer (Roche Diagnostic, Mannheim, Germany) from capillary blood samples.
Time frame: Baseline (Week 0) and Week 12
Triglycerides
Measured using the Accutrend Plus analyzer (Roche Diagnostic, Mannheim, Germany) from capillary blood samples.
Time frame: Baseline (Week 0) and Week 12
Glucose
Measured using the Accutrend Plus analyzer (Roche Diagnostic, Mannheim, Germany) from capillary blood samples.
Time frame: Baseline (Week 0) and Week 12
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