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| ID | Type | Description | Link |
|---|---|---|---|
| PID2019-110906RB-100 | Other Grant/Funding Number | Ministry of Science of Spain | |
| MEJ-NES-2019 | Other Grant/Funding Number | Nestlé Health Sicence S.A. |
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| Name | Class |
|---|---|
| University of Valencia | OTHER |
| Nestle Health Science | INDUSTRY |
| Ministerio de Ciencia e Innovación, Spain | OTHER_GOV |
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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:
Participants:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control | No Intervention | Participants receive neither. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Valencia /Hospital ClÃnico Universitario de València | Valencia | Spain | ES46010 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33672064 | Background | 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. | |
| 36501177 | 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. |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 35782461 | 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. |
| 41677077 | Derived | Olaso-Gonzalez G, Millan-Domingo F, Garcia-Fernandez L, Garcia-Tercero E, Cebrian M, Garcia-Dominguez C, Carbonell JA, Casabo-Valles G, Garcia-Gimenez JL, Tamayo-Torres E, Gambini J, Tarazona-Santabalbina FJ, Vina J, Gomez-Cabrera MC. A Multidomain Lifestyle Intervention Is Associated With Improved Functional Trajectories and Favorable Changes in Epigenetic Aging Markers in Frail Older Adults: A Randomized Controlled Trial. Aging Cell. 2026 Feb;25(2):e70376. doi: 10.1111/acel.70376. |