SarcopeniaFOOP-SarcNCT05485402
Dietary Strategy to Tackle Sarcopenia in Early Elderly Subjects (FOOP-Sarc)
A study testing Refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil), Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) and Maltodextrin in people with Sarcopenia, run by University Rovira i Virgili at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil), Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Foods Such as Virgin Olive Oil Rich in Phenolic Compounds, and Prebiotic Supplementation: Dietary Strategy to Tackle Sarcopenia in Early Elderly Subjects (FOOP-Sarc)
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.
Read the detailed description
The prebiotic supplementation about FOS and inulin was related to gut microbiota transformation an increase in handgrip strength and a reduction of exhaustion in older adults over 65 years old.
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
- Sarcopenia
- Being tested
- Refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil), Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil), Maltodextrin, Prebiotic (FOS and inulin), Nutritional and physical activity recommendations
- Keywords
- early elderly, olive oil, prebiotic supplementation, muscle mass, muscle strength, physical performance
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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).
MaltodextrinDietary supplement
The dosage will be 7,5 g/day of maltodextrin.
Prebiotic (FOS and inulin)Dietary supplement
The dosage will be 7,5 g/day of prebiotic supplement (FOS and inulin).
Nutritional and physical activity recommendationsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group (Group A) | Placebo comparator | Refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil), maltodextrin, and nutritional and physical activity recommendations Receives: 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Secondary outcomes (42)
Body-weight
Measured with calibrated scale in kg
Measured: Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Height
Measured with wall-mounted stadiometer in cm
Measured: Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Body Mass Index
Calculated by weight (kg) divided to height (m2)
Measured: Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Body weight composition
Measured by segmental multifrequency body composition analyser (TANITA MC-780MA; Tanita Corp., Tokyo, Japan).
Measured: Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Waist circumference
Steel measuring tape at the umbilicus in cm.
Measured: Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Sarcopenia assessment_skeletal muscle strength
grip strength, kg: Handheld dynamometer and the maximum value from either hand will be analyzed (Jamar dynamometer; Sammons Preston Rolyan, Bolingbrook, IL)
Measured: Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Sarcopenia assessment_muscle mass
Muscle mass measured by segmental multifrequency body composition analyser (TANITA MC-780MA; Tanita Corp., Tokyo, Japan)
Measured: Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Sarcopenia assessment_muscle physical performance
Gait speed, m/s: length of the walking course divided by the time
Measured: Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Compliance of physical activity recommendations
IPAQ-E Spanish version
Measured: Visit 1 (week 0), visit 2 (week 3), visit 3 (week 6), visit 4 (week 9) visit 5 (week 12), visit 6 (week 24)
Compliance of the dietary recommendations
Dietary record: 3-day dietary record
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Dietary compliance markers
Folin-Ciocalteau method adjusted by creatinine values, measured in 24h urine samples
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Specific phenolic compounds_dietary compliance markers
Specific phenolic compounds and metabolites assessed by Ultra performance liquid chromatography - tandem mass spectrometer (UPLC-MS/MS) in urine samples
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Phenolic metabolites_dietary compliance markers
Phenolic metabolites by UPLC-MS/MS in plasma
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Sarcopenia and Quality of life
SarQoL® test assessed by quality of life test adapted to sarcopenic subjects. It is scored from 0 to 100, where higher values indicate better quality of life.
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Fasting blood glucose (FBG)
by standardized methods in an automated analyzer (Beckman Coulter-Synchron, Galway, Ireland) in (mmol/L)
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Insulin
by standardized methods in an automated analyzer (Beckman Coulter-Synchron, Galway, Ireland) in (IU/mL)
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Homeostasis model assessment index (HOMA index)
Calculated by fasting insulin (μUI/mL) x fasting glucose (mmol/L) / 22,5
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Lipid profile
Total cholesterol (TC), high density lipoprotein cholesterol (HDLc), low density lipoprotein cholesterol (LDLc) and Total triglycerides (TG) in mmol/L by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland)
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Apolipoproteins
Apolipoprotein A1 (ApoA1) and apolipoprotein B100 (ApoB100) in mg/dL by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland)
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Apolipoproteins ratio
Calculated by ApoA1 divided to ApoB100
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Vascular parameters_endothelial function
Ischemic reactive hyperemia (IRH) with Laser-Doppler Linear Periflux 5000 (Perimed AB, Järfälla, Stockholm, Sweden)
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Vascular parameters_blood pressure
Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) in mm Hg by automatic sphygmomanometer (OMRON HEM-907; Peroxfarma, Barcelona, Spain).
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Vascular parameters_pulse pressure
Calculated by SBP - DBP
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Endothelin
Endothelin in pg/mL assessed by Commercial ELISA
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Endothelial dysfunction markers
E-selectin (CD62E), P-selectin (CD62P), Intercellular Cell Adhesion Molecule 1 (ICAM-1 (CD54)) and Vascular Cell Adhesion Molecule 1 (VCAM-1 (CD106) assessed by multi-analyte ELISArray kits.
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Oxidative biomarkers_Oxidized LDL
Oxidized LDL (oxLDL) assessed by commercial ELISA.
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Oxidative biomarkers_Superoxide Dismutase
Superoxide Dismutase (SOD) in U/g Hb assessed by enzymatic assay
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Oxidative biomarkers_Glutathione peroxidase
Glutathione peroxidase (GSHPx) in nmol/mL assessed by enzymatic assay
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Inflammation biomarkers_High sensitivity C-reactive protein
High sensitivity C-reactive protein (hsCRP) in mg/L assessed by Immunoturbidimetry on an autoanalyzer (Roche Diagnostics Systems, Madrid, Spain)
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Inflammation biomarkers_interleukine-6
Interleukine-6 (IL-6) in pg/mL assessed by Immunoturbidimetry on an autoanalyzer (Roche Diagnostics Systems, Madrid, Spain)
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Inflammation biomarkers_uric acid
Uric acid in mg/dL is assessed by Immunoturbidimetry on an autoanalyzer (Roche Diagnostics Systems, Madrid, Spain)
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Inflammation biomarkers_tumour necrosis factor-α
Tumour necrosis factor-α (TNF-α) in pg/mL is assessed by commercial ELISA kit.
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Renal function_creatinine
Creatinine in mg/dL is assessed by standardized methods in a Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain) in 24 h urine samples
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Renal function_glomerular filtration rate
Glomerular filtration rate (GFR) in mL/minutes/1.73m2 is assessed by equation Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Endocrine system
Testosterone (pg/mL) and growth hormone (GH) (pg/mL)) assessed by in a Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain)
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Proteome profiling
Whole proteome assessed by nano Liquid chromatography-mass spectrometry (nLC-MS) according to our previous work.
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Gut microbiota_phyla composition and functionality
Phyla composition and functionality assessed by whole genomic content sequencing. Illumina platform will be used to obtain the metagenomics and metatranscriptomics of each sample following previous protocols developed in Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO-Salud Pública (Valencia)).
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Gut microbiota_short chain fatty acids
Short chain fatty acids (SCFA): bile acids, sterols, buthyrate, and branched chain amino acids and sterols assessed by gas chromatography (GC)
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
wasting and turnover
Myostatin, follistatin, and ratio myostatin/follistatin in serum samples will be measured at V1 and V5 by Human Myostatin MSTN ELISA Kit and Human Follistatin Like Protein 1 (FSTL1) ELISA Kit.
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Muscle mass ultrasound assessment
Muscle mass assessment will be assessed based on dominant upper leg ultrasound. The measurements will be: Subcutaneous adipose tissue thickness (cm); quadriceps muscle thickness (cm); rectus femoris muscle thickness (Y axis) (cm) and cross-sectional area (cm2); pennation angle (º).
Ultrasound assessment will be conducted by VINNO 5 (Vinno (Suzhou) Co., Ltd., China) at HAR-mode with the musculoskeletal (MSK) superficial preset at a frequency of 10 MHz with a linear transducer (Vinno (Suzhou) Co., Ltd., China).
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Muscle mass isokinetic assessment
Muscle mass assessment will be carried out with an isokinetic dynamometer (Biodex System 4; Biodex Medical Systems, New York, USA) based on dominant upper leg.
The parameters assessed at an angular velocity of 180º s-1 and 240º s-1 in leg extension and flexion will be: maximum peak torque (N m), maximum total work (J), mean power (W) and the ratio between the mean power by isokinetic and the rectus femoris cross-sectional area by ultrasound.
Measured: Visit 1 (week 0), visit 5 (week 12)
Frailty
Frailty will be assessed by Fried criteria
Measured: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start1 Sep 2022
- Primary completion31 May 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa Sola, University Rovira i Virgili
- Investigators
- Rosa Solà, Dr, Principal investigator, University Rovira i Virgili, Reus, Tarragona, SpainRosa Maria Valls, Dr, Principal investigator, University Rovira i Virgili, Reus, Tarragona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485402
- Sponsor's protocol ID
- FOOP-Sarc study
- Other IDs
- PID2019-105164RB-I00
- Acronym
- FOOP-Sarc
- Status last verified
- May 2023
- First submitted
- 26 Jul 2022
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28098134Ignacio 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.
PubMed 15762418Beaudart 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.
PubMed 27897430Cruz-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.
PubMed 30312372Besora-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.
PubMed 41787835Besora-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.
PubMed 40184328Besora-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.
PubMed 38794734
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foods Such as Virgin Olive Oil Rich in Phenolic Compounds, and Prebiotic Supplementation: Dietary Strategy to Tackle Sarcopenia in Early Elderly Subjects (FOOP-Sarc)
- ClinicalTrials.gov ID
- NCT05485402
- Acronym / sponsor ID
- FOOP-Sarc / FOOP-Sarc study
- Conditions
- Sarcopenia
- Keywords
- early elderly, olive oil, prebiotic supplementation, muscle mass, muscle strength, physical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The prebiotic supplementation about FOS and inulin was related to gut microbiota transformation an increase in handgrip strength and a reduction of exhaustion in older adults over 65 years old.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group (Group A) | Placebo comparator | Dietary Supplement: Refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil), Dietary Supplement: Maltodextrin, Other: Nutritional and physical activity recommendationsRefined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil), maltodextrin, and nutritional and physical activity recommendations |
| Intervention group (Group B) | Experimental | Dietary Supplement: Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil), Dietary Supplement: Maltodextrin, Other: Nutritional and physical activity recommendationsVirgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil), maltodextrin, and nutritional and physical activity recommendations |
| Intervention group (Group C) | Experimental | 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 recommendationsVirgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil), prebiotic supplementation (FOS and inulin), and nutritional and physical activity recommendations |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Dietary supplement | Control group (Group A) |
| 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). | Dietary supplement | Intervention group (Group B), Intervention group (Group C) |
| MaltodextrinThe dosage will be 7,5 g/day of maltodextrin. | Dietary supplement | Control group (Group A), Intervention group (Group B) |
| Prebiotic (FOS and inulin)The dosage will be 7,5 g/day of prebiotic supplement (FOS and inulin). | Dietary supplement | Intervention group (Group C) |
| Nutritional and physical activity recommendationsThe 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. | Other | Control group (Group A), Intervention group (Group B), Intervention group (Group C) |
Primary outcome
Change in muscle mass
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
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)
42 secondary outcomes
Body-weight
Time frame: Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Height
Time frame: Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Body Mass Index
Time frame: Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Body weight composition
Time frame: Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Waist circumference
Time frame: Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Sarcopenia assessment_skeletal muscle strength
Time frame: Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Sarcopenia assessment_muscle mass
Time frame: Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Sarcopenia assessment_muscle physical performance
Time frame: Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Compliance of physical activity recommendations
Time frame: Visit 1 (week 0), visit 2 (week 3), visit 3 (week 6), visit 4 (week 9) visit 5 (week 12), visit 6 (week 24)
Compliance of the dietary recommendations
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Dietary compliance markers
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Specific phenolic compounds_dietary compliance markers
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Phenolic metabolites_dietary compliance markers
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Sarcopenia and Quality of life
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Fasting blood glucose (FBG)
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Insulin
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Homeostasis model assessment index (HOMA index)
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Lipid profile
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Apolipoproteins
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Apolipoproteins ratio
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Vascular parameters_endothelial function
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Vascular parameters_blood pressure
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Vascular parameters_pulse pressure
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Endothelin
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Endothelial dysfunction markers
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Oxidative biomarkers_Oxidized LDL
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Oxidative biomarkers_Superoxide Dismutase
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Oxidative biomarkers_Glutathione peroxidase
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Inflammation biomarkers_High sensitivity C-reactive protein
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Inflammation biomarkers_interleukine-6
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Inflammation biomarkers_uric acid
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Inflammation biomarkers_tumour necrosis factor-α
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Renal function_creatinine
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Renal function_glomerular filtration rate
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Endocrine system
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Proteome profiling
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Gut microbiota_phyla composition and functionality
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Gut microbiota_short chain fatty acids
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
wasting and turnover
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Muscle mass ultrasound assessment
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Background: PubMed 28098134Rubio 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.
- Background: PubMed 15762418Ignacio 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.
- Background: PubMed 27897430Beaudart 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.
- Background: PubMed 30312372Cruz-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.
- Derived from this study: PubMed 41787835Besora-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.
- Derived from this study: PubMed 40184328Besora-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.
- Derived from this study: PubMed 38794734Besora-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Solà, Dr principal investigator
University Rovira i Virgili, Reus, Tarragona, Spain
Rosa Maria Valls, Dr principal investigator
University Rovira i Virgili, Reus, Tarragona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil), Virgin olive oil rich in phenolic compounds (156 mg hydroxytyrosol and tyrosol/kg oil) and Maltodextrin in people with Sarcopenia, run by University Rovira i Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle mass (time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05485402, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.