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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
39
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).
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).
The dosage will be 7,5 g/day of maltodextrin.
The dosage will be 7,5 g/day of prebiotic supplement (FOS and inulin).
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.
Universitat Rovira i Virgili
Reus, Tarragona, Spain
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)
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Body-weight
Measured with calibrated scale in kg
Time frame: Visit 0 (week -1), visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Height
Measured with wall-mounted stadiometer in cm
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
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
Dietary record: 3-day dietary record
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Apolipoproteins ratio
Calculated by ApoA1 divided to ApoB100
Time frame: 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)
Time frame: 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).
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Vascular parameters_pulse pressure
Calculated by SBP - DBP
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Endothelin
Endothelin in pg/mL assessed by Commercial ELISA
Time frame: 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.
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
Oxidative biomarkers_Oxidized LDL
Oxidized LDL (oxLDL) assessed by commercial ELISA.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: 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)).
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Visit 1 (week 0), visit 5 (week 12)
Frailty
Frailty will be assessed by Fried criteria
Time frame: Visit 1 (week 0), visit 5 (week 12), visit 6 (week 24)
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