Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07015307

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Metabolic Syndrome Aging Atrophy Behavior Body Weight Chronic Disease Disease Attributes Frailty Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Motor Activity Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

European Institute Of Exercise and Health

Elche, Alicante, 03203, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Weight

    Time frame: Baseline (Week 0) and Week 12

    Measured in kilograms using a calibrated digital scale.

  2. Heigth

    Time frame: Baseline (Week 0) and Week 12

    Measured in centimeters using a fixed wall-mounted stadiometer.

  3. BMI

    Time frame: Baseline (Week 0) and Week 12

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

  4. Waist circunference

    Time frame: Baseline (Week 0) and Week 12

    Measured in centimeters using a flexible, non-elastic anthropometric tape at the midpoint between the last rib and the iliac crest.

  5. Body fat percentage

    Time frame: Baseline (Week 0) and Week 12

    Measured using multifrequency bioelectrical impedance.

  6. Health-related quality of life (SF-36 score)

    Time frame: Baseline (Week 0) and Week 12

    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.

  7. Fatigue and perceived effort

    Time frame: Baseline (Week 0) and Week 12

    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.

  8. Energy intake (kcal/day)

    Time frame: Baseline (Week 0) and Week 12

    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.

  9. Carbohydrate intake

    Time frame: Baseline (Week 0) and Week 12

    Average daily carbohydrate intake measured through 3-day dietary records, expressed in grams. Higher values indicate greater carbohydrate consumption.

  10. Protein intake

    Time frame: Baseline (Week 0) and Week 12

    Average daily protein intake measured through 3-day dietary records, expressed in grams. Higher values indicate greater protein consumption.

  11. Fat intake

    Time frame: Baseline (Week 0) and Week 12

    Average daily fat intake measured through 3-day dietary records, expressed in grams. Higher values indicate greater fat consumption.

  12. Daily step count

    Time frame: Baseline (Week 0) and Week 12

    Average number of steps per day measured with an accelerometer-based activity tracker. Higher scores indicate higher physical activity levels.

  13. Active minutes per day

    Time frame: Baseline (Week 0) and Week 12

    Daily time spent in moderate to vigorous physical activity, measured in minutes per day using an accelerometer. Higher scores indicate higher physical activity levels.

  14. Sedentary time per day

    Time frame: Baseline (Week 0) and Week 12

    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).

  15. Sleep quality (PSQI total score)

    Time frame: Baseline (Week 0) and Week 12

    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).

  16. Gait speed (10-meter walk test)

    Time frame: Baseline (Week 0) and Week 12

    Assessed by measuring the time to walk 10 meters at usual pace using infrared photocells (Chronojump, Barcelona, Spain).

  17. Cardiovascular endurance (6-minute walk test)

    Time frame: Baseline (Week 0) and Week 12

    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.

  18. Handgrip strength

    Time frame: Baseline (Week 0) and Week 12

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

  19. Lower-limb isometric strength

    Time frame: Baseline (Week 0) and Week 12

    Assessed through maximum isometric voluntary contraction of the lower limbs using Kinvent force sensors and biofeedback platform.

  20. Sarcopenia diagnosis

    Time frame: Baseline (Week 0) and Week 12

    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.

  21. Basal metabolic rate

    Time frame: Baseline (Week 0) and Week 12

    Measured using indirect calorimetry

  22. Systolic and diastolic blood pressure

    Time frame: Baseline (Week 0) and Week 12

    Assessed using an automatic digital sphygmomanometer (Omron Healthcare, Osaka, Japan), following standardized measurement protocol.

  23. Cholesterol

    Time frame: Baseline (Week 0) and Week 12

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

  24. Triglycerides

    Time frame: Baseline (Week 0) and Week 12

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

  25. Glucose

    Time frame: Baseline (Week 0) and Week 12

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

Sponsors and collaborators

Lead sponsor

University of Alicante

Other

Registry information

Official study title

Study and Design of New Sustainable Exercise and Dietary-nutritional Programs for the Treatment of Metabolic Disorders in Elderly Women

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.