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Synergy of Exercise and Nutrition in Preventing and Treating Frailty

NCT06975540 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-05-16

No results posted yet for this study

Summary

The goal of this clinical study is to learn if combining a nutritional supplement with a multicomponent exercise program can help prevent and treat frailty in community dwelling older adults. The main questions it aims to answer is: Does combining a nutritional supplement (MERITENE) with a multicomponent exercise program improve frailty and functionality in older adults?

Researchers will compare:

* A group receiving both the nutritional supplement and the exercise program (intervention group)
* A control group receiving neither (control group)

Participants:

* take the nutritional supplement (MERITENE, 30g twice a day) for 180 days
* attend (3days/week) supervised exercise sessions as part of the multicomponent program for 180 days (if assigned to the intervention group).
* undergo regular clinical evaluations for frailty, nutritional status, cognitive function, emotional state, and quality of life.

Measurements will include: Changes in frailty status, particularly gait speed, measured using Share-fi criteria, nutritional assessment using the Mini Nutritional Assessment (MNA), physical and cognitive assessments, including Edmonton Frail Scale, MMSE, and Short Physical Performance Battery (SPPB) and a complete biochemical and clinical blood analysis.

Conditions

  • Frail Elderly

Interventions

OTHER

Multidomain physical exercise

The intervention includes a daily intake of two 200-mL of Meritene nutritional supplements (199 Kcal, 16g of protein, 25g of carbs, 3.6g of fats, and enriched with vitamins and minerals/bottle) plus a supervised and personalized multicomponent exercise program. Multicomponent exercise program (MEP) includes endurance, strength, coordination, balance, and flexibility exercises. The sessions last 65 min a day, 3 days/week for 24 weeks. All the sessions are supervised and delivered in groups by sports scientists.

Sponsors & Collaborators

  • University of Valencia

    collaborator OTHER

  • Nestle Health Science

    collaborator INDUSTRY

  • Ministerio de Ciencia e Innovación, Spain

    collaborator OTHER_GOV

  • Fundación para la Investigación del Hospital Clínico de Valencia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-14
Primary Completion
2022-07-29
Completion
2022-07-29

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06975540 on ClinicalTrials.gov