Dietary Strategy to Tackle Sarcopenia in Early Elderly Subjects (FOOP-Sarc)
- Conditions
- Sarcopenia
- Registration Number
- NCT05485402
- Lead Sponsor
- University Rovira i Virgili
- 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.
- 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 135 home-dwelling early elderly volunteers will be included in the intervention (45 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 36 home-dwelling early elderly volunteers will be included in the co-creation process. Specifically, 12 home-dwelling early elderly volunteers will participate in the co-ideation and co-design steps. Additionally, 24 home-dwelling early elderly volunteers will participate in the co-implementation and comparison of recommendations (12 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 36 volunteers from the different steps of the co-creation process.
During the preliminary co-creation phase, there will be 5 visits over 5 weeks. The study visits will be the following: screening visit (V0): to check inclusion/exclusion criteria and, in case of satisfying the inclusion criteria; visits during the intervention (V1, V2, V3); and final study visit (V4). The volunteers that will co-ideate and co-design the recommendations will carry out only the V0, V1, V2, and V4. Instead, the co-implement volunteers will carry out only the visits V0, V3, and V4.
Additionally, during the FOOP-Sarc study, there will be 7 visits in total (6 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 135
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in muscle mass Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24) The change in muscle mass will be assessed by Magnetic Nuclear Resonance (MNR) measured lumbar 3rd vertebra.
- Secondary Outcome Measures
Name Time Method Specific phenolic compounds_dietary compliance markers Visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24) Specific phenolic compounds and metabolites assessed by Ultra performance liquid chromatography - tandem mass spectrometer (UPLC-MS/MS) in urine samples
Phenolic metabolites_dietary compliance markers Visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24) Phenolic metabolites by UPLC-MS/MS in plasma
Oxidative biomarkers_Superoxide Dismutase Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24) Superoxide Dismutase (SOD) in U/g Hb assessed by enzymatic assay
Inflammation biomarkers_High sensitivity C-reactive protein Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24) High sensitivity C-reactive protein (hsCRP) in mg/L assessed by Immunoturbidimetry on an autoanalyzer (Roche Diagnostics Systems, Madrid, Spain)
Renal function_glomerular filtration rate Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24) Glomerular filtration rate (GFR) in mL/minutes/1.73m2 is assessed by equation Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
Body Mass Index Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24) Calculated by weight (kg) divided to height (m2)
Compliance of the dietary recommendations Visit 1 (week 0), visit 2 (week 2), visit 3 (week 4), visit 4 (week 6) visit 5 (week 8), visit 6 (week 10), visit 7 (week 12), visit 8 (week 24) Dietary record: 3-day dietary record
Apolipoproteins Visit 1 (week 0), visit 7 (week 12), visit 8 (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)
Apolipoproteins ratio Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24) Calculated by ApoA1 divided to ApoB100
Endothelin Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24) Endothelin in pg/mL assessed by Commercial ELISA
Oxidative biomarkers_Glutathione peroxidase Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24) Glutathione peroxidase (GSHPx) in nmol/mL assessed by enzymatic assay
Height Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24) Measured with wall-mounted stadiometer in cm
Sarcopenia assessment_muscle physical performance Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24) Gait speed, m/s: length of the walking course divided by the time
Compliance of physical activity recommendations Visit 1 (week 0), visit 2 (week 2), visit 3 (week 4), visit 4 (week 6) visit 5 (week 8), visit 6 (week 10), visit 7 (week 12), visit 8 (week 24) IPAQ-E Spanish version
Sarcopenia and Quality of life Visit 1 (week 0), visit 7 (week 12), visit 8 (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.
Vascular parameters_endothelial function Visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24) Ischemic reactive hyperemia (IRH) with Laser-Doppler Linear Periflux 5000 (Perimed AB, Järfälla, Stockholm, Sweden)
Vascular parameters_pulse pressure Visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24) Calculated by SBP - DBP
Sarcopenia assessment_muscle mass Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24) Muscle mass, wasting and turnover: assessed by Magnetic Nuclear Resonance (MNR) measured lumbar 3rd vertebra
Vascular parameters_blood pressure Visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24) Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) in mm Hg by automatic sphygmomanometer (OMRON HEM-907; Peroxfarma, Barcelona, Spain).
Endothelial dysfunction markers Visit 1 (week 0), visit 7 (week 12), visit 8 (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.
Oxidative biomarkers_Oxidized LDL Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24) Oxidized LDL (oxLDL) assessed by commercial ELISA.
Inflammation biomarkers_uric acid Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24) Uric acid in mg/dL is assessed by Immunoturbidimetry on an autoanalyzer (Roche Diagnostics Systems, Madrid, Spain)
Renal function_creatinine Visit 1 (week 0), visit 7 (week 12), visit 8 (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
Body weight composition Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24) Measured by bioimpedance (Tanita SC 330-S)
Waist circumference Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24) Steel measuring tape at the umbilicus in cm.
Sarcopenia assessment_skeletal muscle strength Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24) grip strength, kg: Handheld dynamometer and the maximum value from either hand will be analyzed (Jamar dynamometer; Sammons Preston Rolyan, Bolingbrook, IL)
Dietary compliance markers Visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24) Folin-Ciocalteau method adjusted by creatinine values, measured in 24h urine samples
Fasting blood glucose (FBG) Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24) by standardized methods in an automated analyzer (Beckman Coulter-Synchron, Galway, Ireland) in (mmol/L)
Insulin Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24) by standardized methods in an automated analyzer (Beckman Coulter-Synchron, Galway, Ireland) in (IU/mL)
Homeostasis model assessment index (HOMA index) Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24) Calculated by fasting insulin (μUI/mL) x fasting glucose (mmol/L) / 22,5
Lipid profile Visit 1 (week 0), visit 7 (week 12), visit 8 (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)
Inflammation biomarkers_interleukine-6 Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24) Interleukine-6 (IL-6) in pg/mL assessed by Immunoturbidimetry on an autoanalyzer (Roche Diagnostics Systems, Madrid, Spain)
Gut microbiota_phyla composition and functionality Visit 1 (week 0), visit 7 (week 12), visit 8 (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)).
Inflammation biomarkers_tumour necrosis factor-α Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24) Tumour necrosis factor-α (TNF-α) in pg/mL is assessed by commercial ELISA kit.
Endocrine system Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24) Testosterone (pg/mL) and growth hormone (GH) (pg/mL)) assessed by in a Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain)
Proteome profiling Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24) Whole proteome assessed by nano Liquid chromatography-mass spectrometry (nLC-MS) according to our previous work.
Gut microbiota_short chain fatty acids Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24) Short chain fatty acids (SCFA): bile acids, sterols, buthyrate, and branched chain amino acids and sterols assessed by gas chromatography (GC)
Body-weight Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24) Measured with calibrated scale in kg
Trial Locations
- Locations (1)
Universitat Rovira i Virgili
🇪🇸Reus, Tarragona, Spain
Universitat Rovira i Virgili🇪🇸Reus, Tarragona, SpainRosa Solà, DrContact0034 977 75 9369rosa.sola@urv.catRosa Maria Valls, DrContact0034 977 759 375rosamaria.valls@urv.cat