Synergy of Exercise and Nutrition in Preventing and Treating Frailty

NCT06975540 | Completed

• 2 other identifiers: MEJ-NES-2019PID2019-110906RB-100
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Frailty; Malnutrition; Physical exercise program; Nutritional supplementation

Outcome Measures

Primary Outcomes (1)

• Frailty according to the Survey of Health, Ageing and Retirement in Europe Frailty Index (SHARE-FI)

  Change in frailty status assessed by Fried's criteria after 180 days.

  24 weeks (180 days)

Study Arms (2)

Intervention

EXPERIMENTAL

Participants take the nutritional supplement (MERITENE, 30g twice a day) and attend supervised exercise sessions as part of the multicomponent program (3days/week) for 180 days.

Other: Multidomain physical exercise

Control

NO INTERVENTION

Participants receive neither.

Interventions

Multidomain physical exercise OTHER

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.

Intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• i) men and women aged 70 years or older; ii) sedentary (less than three hours of weekly physical activity), iii) frail according to the Survey of Health, Ageing and Retirement in Europe Frailty Index (SHARE-FI); iv) gait speed lower or equal than 0.8 m/sec, v) community dwellers

You may not qualify if:

• i) life expectancy from the moment of selection lower than twelve months by any cause; ii) poorly controlled diabetes (glycated hemoglobin \> 9%); iii) cognitive impairment (score less than 17 in the MMSE); iv) disability (score less than 50 points on Barthel's Scale); v) acute coronary event in the previous year; vi) hospital admission in the previous three months for any reason; vii) oncologic patient with active treatment with chemotherapy or radiotherapy; viii) major non-ambulatory surgery in the previous six months; ix) patient with a coronary event in the previous twelve months; x) institutionalized patient; xi) New York Heart Association class 3 to 4 baseline dyspnea; xii) lactose intolerance; xiii) being supplemented with a multivitamin or a protein-rich food; xiv) refusal to sign the informed consent.

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead
• University of Valencia: collaborator
• Nestle Health Science: collaborator
• Ministerio de Ciencia e Innovación, Spain: collaborator

Study Sites (1)

University of Valencia /Hospital Clínico Universitario de València

Valencia, Spain, ES46010, Spain

Location

Related Publications (3)

• Garcia-Gimenez JL, Mena-Molla S, Tarazona-Santabalbina FJ, Vina J, Gomez-Cabrera MC, Pallardo FV. Implementing Precision Medicine in Human Frailty through Epigenetic Biomarkers. Int J Environ Res Public Health. 2021 Feb 15;18(4):1883. doi: 10.3390/ijerph18041883.

  PMID: 33672064 BACKGROUND

• Millan-Domingo F, Tarazona-Santabalbina FJ, Carretero A, Olaso-Gonzalez G, Vina J, Gomez-Cabrera MC. Real-Life Outcomes of a Multicomponent Exercise Intervention in Community-Dwelling Frail Older Adults and Its Association with Nutritional-Related Factors. Nutrients. 2022 Dec 3;14(23):5147. doi: 10.3390/nu14235147.

  PMID: 36501177 BACKGROUND

• Arc-Chagnaud C, Millan F, Salvador-Pascual A, Correas AG, Olaso-Gonzalez G, De la Rosa A, Carretero A, Gomez-Cabrera MC, Vina J. Reversal of age-associated frailty by controlled physical exercise: The pre-clinical and clinical evidences. Sports Med Health Sci. 2019 Sep 10;1(1):33-39. doi: 10.1016/j.smhs.2019.08.007. eCollection 2019 Dec.

  PMID: 35782461 BACKGROUND

MeSH Terms

Conditions

Frailty; Malnutrition

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: October 14, 2019
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

ES (1)