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

NCT07015307 | Active Not Recruiting

• 1 other identifier: UA-2025-05-19_1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Mediterranean diet; Functional training; Women over 65; Lifestyle intervention; Nutrition and exercise

Outcome Measures

Primary Outcomes (25)

• Weight

  Measured in kilograms using a calibrated digital scale.

  Baseline (Week 0) and Week 12

• Heigth

  Measured in centimeters using a fixed wall-mounted stadiometer.

  Baseline (Week 0) and Week 12

• BMI

  Calculated as weight (kg) divided by height squared (m²), using measurements taken as above.

  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.

  Baseline (Week 0) and Week 12

• Body fat percentage

  Measured using multifrequency bioelectrical impedance.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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).

  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).

  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.

  Baseline (Week 0) and Week 12

• Handgrip strength

  Measured using a digital hand dynamometer. Maximum isometric voluntary contraction recorded in the dominant hand.

  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.

  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.

  Baseline (Week 0) and Week 12

• Basal metabolic rate

  Measured using indirect calorimetry

  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.

  Baseline (Week 0) and Week 12

• Cholesterol

  Measured using the Accutrend Plus analyzer (Roche Diagnostic, Mannheim, Germany) from capillary blood samples.

  Baseline (Week 0) and Week 12

• Triglycerides

  Measured using the Accutrend Plus analyzer (Roche Diagnostic, Mannheim, Germany) from capillary blood samples.

  Baseline (Week 0) and Week 12

• Glucose

  Measured using the Accutrend Plus analyzer (Roche Diagnostic, Mannheim, Germany) from capillary blood samples.

  Baseline (Week 0) and Week 12

Study Arms (5)

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.

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.

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.

Behavioral: Combined Sustainable Diet and Exercise Program

Interventions

Sustainable Diet Program BEHAVIORAL

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.

Diet Intervention

Supervised Physical Exercise Program BEHAVIORAL

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.

Exercise Intervention

Combined Sustainable Diet and Exercise Program BEHAVIORAL

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.

Combined Diet + Exercise

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: This study is exclusively for biologically female participants aged 65 and older due to its focus on aging-related metabolic changes in women.
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alicante: lead

Study Sites (1)

European Institute Of Exercise and Health

Elche, Alicante, 03203, Spain

Location

MeSH Terms

Conditions

Metabolic Syndrome; Sarcopenia; Obesity; Chronic Disease; Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Disease Attributes; Pathologic Processes; Behavior

Study Officials

• Alejandro Martínez Rodríguez, Dr.

  Alicante University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher performing the statistical analysis will not know which intervention each group received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alejandro Martínez-Rodríguez

Model Details: Participants will be randomly assigned to parallel intervention groups (dietary strategy, physical exercise, or combined). No crossover will occur between arms.

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)