Dietary Strategy to Tackle Sarcopenia in Early Elderly Subjects (FOOP-Sarc)

NCT05485402 | Completed DMC

• 2 other identifiers: FOOP-Sarc studyPID2019-105164RB-I00
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the present study is to add knowledge of the potential health effects and mechanism of action by a dietary strategy based on a VOO rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) alone or combination with prebiotic supplementation based on fructooligosaccharides (FOS) and inulin to tackle sarcopenia by improving skeletal muscle mass and function and CVD risk factors in early elderly (60-80 years) home-dwelling sarcopenic subjects. 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.

Conditions

Sarcopenia

Keywords

early elderly; olive oil; prebiotic supplementation; muscle mass; muscle strength; physical performance

Outcome Measures

Primary Outcomes (1)

• Change in muscle mass

  The change in muscle mass will be assess by the change in skeletal muscle mass index (kg/m2) measured by segmental multifrequency body composition analyser (TANITA MC-780MA; Tanita Corp., Tokyo, Japan)

  Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)

Secondary Outcomes (42)

• Body-weight

  Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)

• Height

  Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)

• Body Mass Index

  Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)

• Body weight composition

  Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)

• Waist circumference

  Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)

Study Arms (3)

Control group (Group A)

PLACEBO COMPARATOR

Refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil), maltodextrin, and nutritional and physical activity recommendations

Dietary Supplement: Refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil); Dietary Supplement: Maltodextrin; Other: Nutritional and physical activity recommendations

Intervention group (Group B)

EXPERIMENTAL

Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil), maltodextrin, and nutritional and physical activity recommendations

Dietary Supplement: Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil); Dietary Supplement: Maltodextrin; Other: Nutritional and physical activity recommendations

Intervention group (Group C)

EXPERIMENTAL

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

Dietary Supplement: Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil); Dietary Supplement: Prebiotic (FOS and inulin); Other: Nutritional and physical activity recommendations

Interventions

Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) DIETARY_SUPPLEMENT

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).

Intervention group (Group B); Intervention group (Group C)

Nutritional and physical activity recommendations OTHER

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.

Control group (Group A); Intervention group (Group B); Intervention group (Group C)

Refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil) DIETARY_SUPPLEMENT

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).

Control group (Group A)

Maltodextrin DIETARY_SUPPLEMENT

The dosage will be 7,5 g/day of maltodextrin.

Control group (Group A); Intervention group (Group B)

Prebiotic (FOS and inulin) DIETARY_SUPPLEMENT

The dosage will be 7,5 g/day of prebiotic supplement (FOS and inulin).

Intervention group (Group C)

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women with and age equal to or greater than 60 years and until 80 years.
• 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)

You may not qualify if:

• Type 2 or insulin-dependent diabetes diagnosed.
• 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.
• Institutionalized elderly.
• Failure to follow the study guidelines.

Sponsors & Collaborators

• University Rovira i Virgili: lead

Study Sites (1)

Universitat Rovira i Virgili

Reus, Tarragona, 43201, Spain

Location

Related Publications (7)

• 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.

  PMID: 28098134 BACKGROUND

• 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.

  PMID: 15762418 BACKGROUND

• 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.

  PMID: 27897430 BACKGROUND

• 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.

  PMID: 30312372 BACKGROUND

• Besora-Moreno M, Jimenez-Ten Hoevel C, Queral J, Bernal G, Perez-Merino L, Puzo J, Conangla-Ferrin L, Constance Sleebos L, van Helden W, Llaurado E, Valls RM, Sola R, Pedret A. Effects of Phenolic-Rich Extra Virgin Olive Oil and Prebiotics on Sarcopenia in Older Adults: FOOP-Sarc Project. J Cachexia Sarcopenia Muscle. 2026 Apr;17(2):e70247. doi: 10.1002/jcsm.70247.

  PMID: 41787835 DERIVED

• 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.

  PMID: 40184328 DERIVED

• 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.

  PMID: 38794734 DERIVED

MeSH Terms

Conditions

Sarcopenia

Interventions

3,4-dihydroxyphenylethanol; maltodextrin; Prebiotics; Inulin

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages; Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Fructans

Study Officials

• Rosa Solà, Dr

  University Rovira i Virgili, Reus, Tarragona, Spain

  PRINCIPAL INVESTIGATOR

• Rosa Maria Valls, Dr

  University Rovira i Virgili, Reus, Tarragona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Dr.

Model Details: Randomized, controlled, parallel and double-blind intervention study. The total duration of the study will be 24 weeks (12-weeks of intervention and 12-weeks of follow-up). The study will have three arms of intervention. The intervention products will be prebiotic supplement based on FOS and inulin or virgin olive oil rich in phenolic compounds with 156 mg hydroxytyrosol and tyrosol/kg oil. The placebo will be refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil) or maltodextrin. Both with the same format and appearance, to ensure the double-blind intervention. 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.

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 3, 2022
• Study Start: September 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2024
• Last Updated: December 22, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)