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Completed

NCT Number: NCT05485402

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.

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Key information

Conditions

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

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat Rovira i Virgili

Reus, Tarragona, 43201, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

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).

Maltodextrin

Dietary 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 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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Body-weight

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

    Measured with calibrated scale in kg

  2. Height

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

    Measured with wall-mounted stadiometer in cm

  3. Body Mass Index

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

    Calculated by weight (kg) divided to height (m2)

  4. Body weight composition

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

    Measured by segmental multifrequency body composition analyser (TANITA MC-780MA; Tanita Corp., Tokyo, Japan).

  5. Waist circumference

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

    Steel measuring tape at the umbilicus in cm.

  6. Sarcopenia assessment_skeletal muscle strength

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

    grip strength, kg: Handheld dynamometer and the maximum value from either hand will be analyzed (Jamar dynamometer; Sammons Preston Rolyan, Bolingbrook, IL)

  7. Sarcopenia assessment_muscle mass

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

    Muscle mass measured by segmental multifrequency body composition analyser (TANITA MC-780MA; Tanita Corp., Tokyo, Japan)

  8. Sarcopenia assessment_muscle physical performance

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

    Gait speed, m/s: length of the walking course divided by the time

  9. 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)

    IPAQ-E Spanish version

  10. Compliance of the dietary recommendations

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

    Dietary record: 3-day dietary record

  11. Dietary compliance markers

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

    Folin-Ciocalteau method adjusted by creatinine values, measured in 24h urine samples

  12. Specific phenolic compounds_dietary compliance markers

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

    Specific phenolic compounds and metabolites assessed by Ultra performance liquid chromatography - tandem mass spectrometer (UPLC-MS/MS) in urine samples

  13. Phenolic metabolites_dietary compliance markers

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

    Phenolic metabolites by UPLC-MS/MS in plasma

  14. Sarcopenia and Quality of life

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

    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.

  15. Fasting blood glucose (FBG)

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

    by standardized methods in an automated analyzer (Beckman Coulter-Synchron, Galway, Ireland) in (mmol/L)

  16. Insulin

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

    by standardized methods in an automated analyzer (Beckman Coulter-Synchron, Galway, Ireland) in (IU/mL)

  17. Homeostasis model assessment index (HOMA index)

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

    Calculated by fasting insulin (μUI/mL) x fasting glucose (mmol/L) / 22,5

  18. Lipid profile

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

    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)

  19. Apolipoproteins

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

    Apolipoprotein A1 (ApoA1) and apolipoprotein B100 (ApoB100) in mg/dL by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland)

  20. Apolipoproteins ratio

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

    Calculated by ApoA1 divided to ApoB100

  21. Vascular parameters_endothelial function

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

    Ischemic reactive hyperemia (IRH) with Laser-Doppler Linear Periflux 5000 (Perimed AB, Järfälla, Stockholm, Sweden)

  22. Vascular parameters_blood pressure

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

    Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) in mm Hg by automatic sphygmomanometer (OMRON HEM-907; Peroxfarma, Barcelona, Spain).

  23. Vascular parameters_pulse pressure

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

    Calculated by SBP - DBP

  24. Endothelin

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

    Endothelin in pg/mL assessed by Commercial ELISA

  25. Endothelial dysfunction markers

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

    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.

  26. Oxidative biomarkers_Oxidized LDL

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

    Oxidized LDL (oxLDL) assessed by commercial ELISA.

  27. Oxidative biomarkers_Superoxide Dismutase

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

    Superoxide Dismutase (SOD) in U/g Hb assessed by enzymatic assay

  28. Oxidative biomarkers_Glutathione peroxidase

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

    Glutathione peroxidase (GSHPx) in nmol/mL assessed by enzymatic assay

  29. Inflammation biomarkers_High sensitivity C-reactive protein

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

    High sensitivity C-reactive protein (hsCRP) in mg/L assessed by Immunoturbidimetry on an autoanalyzer (Roche Diagnostics Systems, Madrid, Spain)

  30. Inflammation biomarkers_interleukine-6

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

    Interleukine-6 (IL-6) in pg/mL assessed by Immunoturbidimetry on an autoanalyzer (Roche Diagnostics Systems, Madrid, Spain)

  31. Inflammation biomarkers_uric acid

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

    Uric acid in mg/dL is assessed by Immunoturbidimetry on an autoanalyzer (Roche Diagnostics Systems, Madrid, Spain)

  32. Inflammation biomarkers_tumour necrosis factor-α

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

    Tumour necrosis factor-α (TNF-α) in pg/mL is assessed by commercial ELISA kit.

  33. Renal function_creatinine

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

    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

  34. Renal function_glomerular filtration rate

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

    Glomerular filtration rate (GFR) in mL/minutes/1.73m2 is assessed by equation Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).

  35. Endocrine system

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

    Testosterone (pg/mL) and growth hormone (GH) (pg/mL)) assessed by in a Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain)

  36. Proteome profiling

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

    Whole proteome assessed by nano Liquid chromatography-mass spectrometry (nLC-MS) according to our previous work.

  37. Gut microbiota_phyla composition and functionality

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

    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)).

  38. Gut microbiota_short chain fatty acids

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

    Short chain fatty acids (SCFA): bile acids, sterols, buthyrate, and branched chain amino acids and sterols assessed by gas chromatography (GC)

  39. wasting and turnover

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

    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.

  40. Muscle mass ultrasound assessment

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

    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).

  41. Muscle mass isokinetic assessment

    Time frame: Visit 1 (week 0), visit 5 (week 12)

    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.

  42. Frailty

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

    Frailty will be assessed by Fried criteria

Sponsors and collaborators

Lead sponsor

University Rovira i Virgili

Other

Registry information

Official study 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)

Acronym: FOOP-Sarc

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 3, 2022
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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