Dietary Strategy to Tackle Sarcopenia in Early Elderly Subjects (FOOP-Sarc)
NCT ID: NCT05485402
Last Updated: 2025-12-22
Study Results
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Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2022-09-01
2024-05-31
Brief Summary
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The specific objectives:
* To determine the compliance food intake biomarkers of VOO in 24h urine samples and prebiotic intake in faecal samples.
* To evaluate the effect of the NFOC-diet supplemented by VOO rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) alone or in combination with prebiotic supplementation (FOS and inulin) on the improvement of muscle mass, muscle performance, gait performance, cardiovascular disease risk factors (inflammation, oxidation and endothelial function), and gut microbiota, in sarcopenic young-elderly subjects.
* To assess the mechanisms of action of the NFOC-diet supplemented by VOO rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) alone or in combination with prebiotic supplementation (FOS and inulin) involved in the development of sarcopenia and cardiovascular disease in vivo and in vitro cellular models.
* To determine if the effects achieved after the intervention (12 weeks of intervention) will be sustained 12 weeks after the FOOP-Sarc intervention cessation (12 weeks of intervention + 12 weeks of follow-up), by assessing the sarcopenia and CVD risk factors in sarcopenic early elderly subjects.
* To co-create nutritional and physical activity recommendations of FOOP-Sarc study based on sarcopenia improvement by a sample of volunteers of the FOOP-Sarc study, and to assess the adherence and the effectivity of the recommendations, in comparison to standard recommendations created by researchers, the satisfaction and engagement experience in a co-creation process, and the usability of recommendations.
Detailed Description
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In the role of a nutritional intervention for the treatment of sarcopenia, an adequate intake of protein, especially leucine, vitamin D and antioxidant nutrients are recommended. In particular, dietary protein is a key anabolic stimulus for muscle protein synthesis. Moreover, food such as, virgin olive oil (VOO) can be involved in sarcopenia, by modulation of pro-inflammatory cytokines and could attenuate sarcopenic symptomology.
On the other hand, physical activity (PA) is an important aspect to avoid loss of muscle mass, for this reason, in sarcopenic subjects it is recommended to spend 150 min/week of moderate to vigorous physical activity.
A total of 39 home-dwelling early elderly volunteers will be included in the intervention (13 in each arm of the intervention). The total duration of the study will be 24 weeks (12-week period of dietary-lifestyle treatment and a 12-week period of follow-up after intervention cessation). Additionally, a total of 13 home-dwelling early elderly volunteers will be included in the co-creation process. Specifically, 7 home-dwelling early elderly volunteers will participate in the co-ideation and co-design steps. Additionally, 6 home-dwelling early elderly volunteers will participate in the co-implementation and comparison of recommendations (3 in each arm of intervention). The sample of volunteers that will co-implement will be randomized and different from the sample of volunteers that will co-ideate and co-design the recommendations. The co-evaluation step will include all 13 volunteers from the different steps of the co-creation process.
During the preliminary co-creation phase, there will be 5 visits over 6 weeks. A screening visit (V0) and one visit for each co-creation stage (co-ideation \[V1\], co-design \[V2\], co-implementation \[V3\] and co-evaluation \[V4\]). The volunteers who participated in the co-ideation and co-design stages had a total of 4 visits (V0, V1, V2 and the co-evaluation \[V4\] at the end of the co-design stage). The volunteers who participated in the co-implementation stage had a total of 3 visits (V0, V3 and V4).
Additionally, during the FOOP-Sarc study, there will be 6 visits in total (5 visits during the intervention period and 1 follow-up visit). Of these visits, 4 will be face-to-face and 3 by telephone. The study visits will be the following: screening visit (V0, face-to-face): to check inclusion/exclusion criteria and, in case of satisfying the inclusion criteria; basal visit (V1); visits during the intervention (V2, telephone; V3, telephone; V4, telephone); final study visit (V5, face-to-face); and follow-up visit (V6, face-to-face): follow-up visit 12-week after intervention cessation. In visits V0, V1, V5, and V6 volunteers must present themselves in fasting conditions of 8 hours to obtain blood. In visits V1, V5, and V6 volunteers must bring urine and feaces samples.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
All the volunteers will receive NFOC-diet and physical activity recommendations co-created during the co-creation study. The nutritional recommendations are based on DASH diet and foods rich in protein (in particular, leucine), vitamin D, polyunsaturated acids, phosphorus and iron. The physical activity recommendations are 150 min/week of physical activity, with at least two sessions focused on motor strength.
PREVENTION
TRIPLE
Study Groups
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Control group (Group A)
Refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil), maltodextrin, and nutritional and physical activity recommendations
Refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil)
The dosage will be 30 ml/day of refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil) used as a dressing (without heat).
Maltodextrin
The dosage will be 7,5 g/day of maltodextrin.
Nutritional and physical activity recommendations
The nutritional recommendations are based on DASH diet and foods rich in protein (in particular, leucine) and vitamin D, polyunsaturated acids, phosphorus and iron. The physical activity recommendations are 150 min/week of physical activity, with at least two sessions dedicated to the development of motor strength.
Intervention group (Group B)
Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil), maltodextrin, and nutritional and physical activity recommendations
Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil)
The dosage will be 30 ml/day of virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) used as a dressing (without heat).
Maltodextrin
The dosage will be 7,5 g/day of maltodextrin.
Nutritional and physical activity recommendations
The nutritional recommendations are based on DASH diet and foods rich in protein (in particular, leucine) and vitamin D, polyunsaturated acids, phosphorus and iron. The physical activity recommendations are 150 min/week of physical activity, with at least two sessions dedicated to the development of motor strength.
Intervention group (Group C)
Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil), prebiotic supplementation (FOS and inulin), and nutritional and physical activity recommendations
Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil)
The dosage will be 30 ml/day of virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) used as a dressing (without heat).
Prebiotic (FOS and inulin)
The dosage will be 7,5 g/day of prebiotic supplement (FOS and inulin).
Nutritional and physical activity recommendations
The nutritional recommendations are based on DASH diet and foods rich in protein (in particular, leucine) and vitamin D, polyunsaturated acids, phosphorus and iron. The physical activity recommendations are 150 min/week of physical activity, with at least two sessions dedicated to the development of motor strength.
Interventions
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Refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil)
The dosage will be 30 ml/day of refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil) used as a dressing (without heat).
Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil)
The dosage will be 30 ml/day of virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) used as a dressing (without heat).
Maltodextrin
The dosage will be 7,5 g/day of maltodextrin.
Prebiotic (FOS and inulin)
The dosage will be 7,5 g/day of prebiotic supplement (FOS and inulin).
Nutritional and physical activity recommendations
The nutritional recommendations are based on DASH diet and foods rich in protein (in particular, leucine) and vitamin D, polyunsaturated acids, phosphorus and iron. The physical activity recommendations are 150 min/week of physical activity, with at least two sessions dedicated to the development of motor strength.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent provided before the initial visit.
* Sarcopenia assessment: low muscle strength based on grip dynamometry, kg (men \<30 kg; women \<20 kg) or low skeletal muscle mass index (SMI) based on bioimpedance analysis (BIA), kg/m2 (men \<8,87 kg/m2; women \<6,42 kg/m2) or low physical performance or physical function based on 4m gait speed, m/s (≤0,8 m/s)
Exclusion Criteria
* Anemia (hemoglobin ≤13 g/dL in men and ≤12 g/dL in women).
* Intestinal malabsorption diseases.
* Fructose and/or sucrose intolerance.
* Malnutrition (assessed by albumin \<3,5 g/dl).
* Renal diseases.
* Chronic alcoholism.
* Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study.
* Institutionalized elderly.
* Failure to follow the study guidelines.
60 Years
80 Years
ALL
Yes
Sponsors
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University Rovira i Virgili
OTHER
Responsible Party
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Rosa Sola
Full Professor, Dr.
Principal Investigators
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Rosa Solà, Dr
Role: PRINCIPAL_INVESTIGATOR
University Rovira i Virgili, Reus, Tarragona, Spain
Rosa Maria Valls, Dr
Role: PRINCIPAL_INVESTIGATOR
University Rovira i Virgili, Reus, Tarragona, Spain
Locations
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Universitat Rovira i Virgili
Reus, Tarragona, Spain
Countries
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References
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Rubio Castaneda FJ, Tomas Aznar C, Muro Baquero C. [Validity, Reliability and Associated Factors of the International Physical Activity Questionnaire Adapted to Elderly (IPAQ-E)]. Rev Esp Salud Publica. 2017 Jan 18;91:e201701004. Spanish.
Ignacio de Ulibarri J, Gonzalez-Madrono A, de Villar NG, Gonzalez P, Gonzalez B, Mancha A, Rodriguez F, Fernandez G. CONUT: a tool for controlling nutritional status. First validation in a hospital population. Nutr Hosp. 2005 Jan-Feb;20(1):38-45.
Beaudart C, Biver E, Reginster JY, Rizzoli R, Rolland Y, Bautmans I, Petermans J, Gillain S, Buckinx F, Dardenne N, Bruyere O. Validation of the SarQoL(R), a specific health-related quality of life questionnaire for Sarcopenia. J Cachexia Sarcopenia Muscle. 2017 Apr;8(2):238-244. doi: 10.1002/jcsm.12149. Epub 2016 Oct 22.
Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
Besora-Moreno M, Sepulveda C, Queral J, Jimenez-Ten Hoevel C, Pedret A, Tarro L, Valls RM, Sola R, Llaurado E. Participatory Research in Clinical Studies: An Innovative Approach to Co-creating Nutritional and Physical Activity Recommendations for Older Adults With Sarcopenia (FOOP-Sarc Project). Health Expect. 2025 Apr;28(2):e70187. doi: 10.1111/hex.70187.
Besora-Moreno M, Llaurado E, Jimenez-Ten Hoevel C, Sepulveda C, Queral J, Bernal G, Perez-Merino L, Martinez-Hervas S, Alabadi B, Ortega Y, Valls RM, Sola R, Pedret A. New Perspectives for Low Muscle Mass Quantity/Quality Assessment in Probable Sarcopenic Older Adults: An Exploratory Analysis Study. Nutrients. 2024 May 15;16(10):1496. doi: 10.3390/nu16101496.
Other Identifiers
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FOOP-Sarc study
Identifier Type: -
Identifier Source: org_study_id
PID2019-105164RB-I00
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id