Dietary Strategy to Tackle Sarcopenia in Early Elderly Subjects (FOOP-Sarc)
Study Details
Study Description
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 (500 ppm) 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 (60-74 years) home-dwelling sarcopenic subjects.
The specific objectives:
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To determine the compliance food intake biomarkers of VOO in 24h urine samples and prebiotic intake in faecal samples.
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To evaluate the effect of the NFOC-diet supplemented by VOO rich in phenolic compounds (500 ppm) 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.
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To assess the mechanisms of action of the NFOC-diet supplemented by VOO rich in phenolic compounds (500 ppm) 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.
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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.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 9 visits in total (8 visits during the intervention period and 1 follow-up visit). Of these visits, 6 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, face-to-face; V4, telephone; V5, face-to-face; V6, telephone); final study visit (V7, face-to-face); and follow-up visit (V8, face-to-face): follow-up visit 12-week after intervention cessation. In visits V0, V1, V2, and V4 volunteers must present themselves in fasting conditions of 8 hours to obtain blood. In visits V1, V3, V5, V7, and V8 volunteers must bring urine samples. In visits V1, V7 and V8 volunteers must get faeces samples too. In order to measure the changes in muscle mass, five days prior to the visit V1 and approximately 3 days prior to the visits V7 and V8, volunteers must have a Nuclear Magnetic Resonance (NMR).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Control group (Group A) Virgin olive oil (80 ppm), maltodextrin, and nutritional and physical activity recommendations |
Dietary Supplement: Virgin olive oil (80 ppm)
The dosage will be 30 ml/day of virgin olive oil (80 ppm) used as a dressing (without heat).
Dietary Supplement: Maltodextrin
The dosage will be 7,5 g/day of maltodextrin.
Other: Nutritional and physical activity recommendations
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.
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| Experimental: Intervention group (Group B) Virgin olive oil rich in phenolic compounds (500 ppm), maltodextrin, and nutritional and physical activity recommendations |
Dietary Supplement: Virgin olive oil rich in phenolic compounds (500 ppm)
The dosage will be 30 ml/day of virgin olive oil rich in phenolic compounds (500 ppm) used as a dressing (without heat).
Dietary Supplement: Maltodextrin
The dosage will be 7,5 g/day of maltodextrin.
Other: Nutritional and physical activity recommendations
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.
|
| Experimental: Intervention group (Group C) Virgin olive oil rich in phenolic compounds (500 ppm), prebiotic supplementation (FOS and inulin), and nutritional and physical activity recommendations |
Dietary Supplement: Virgin olive oil rich in phenolic compounds (500 ppm)
The dosage will be 30 ml/day of virgin olive oil rich in phenolic compounds (500 ppm) used as a dressing (without heat).
Dietary Supplement: Prebiotic (FOS and inulin)
The dosage will be 7,5 g/day of prebiotic supplement (FOS and inulin).
Other: Nutritional and physical activity recommendations
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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)
- 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)
- 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
- 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
- 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
- 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
- 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
- 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.
- 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)
- 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
- 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_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).
- 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
- Endothelin [Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)]
Endothelin in pg/mL assessed by Commercial ELISA
- 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.
- 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
- 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
- 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)
- 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)
- 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)
- 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.
- 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
- 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).
- 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_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)).
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men and women with and age equal to or greater than 60 years and less than 75 years
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Written informed consent provided before the initial visit
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Sarcopenia assessment: low muscle strength based on grip dynamometry, kg (men <27 kg; women <16 kg) or low muscle performance based on gait speed, m/s (≤0.8)
Exclusion Criteria:
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Type 2 or insulin-dependent diabetes diagnosed
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Anemia (haemoglobin ≤13 g/dL in men and ≤12 g/dL in women)
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Intestinal malabsorption diseases
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Malnutrition (assessed by CONUT test ≥2 points/12 points)
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Renal diseases
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Chronic alcoholism
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Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study
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Institutionalized elderly
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Failure to follow the study guidelines
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitat Rovira i Virgili | Reus | Tarragona | Spain | 43201 |
Sponsors and Collaborators
- University Rovira i Virgili
Investigators
- Principal Investigator: Rosa Solà, Dr, University Rovira i Virgili, Reus, Tarragona, Spain
- Principal Investigator: Rosa Maria Valls, Dr, University Rovira i Virgili, Reus, Tarragona, Spain
Study Documents (Full-Text)
None provided.More Information
Publications
- Beaudart C, Biver E, Reginster JY, Rizzoli R, Rolland Y, Bautmans I, Petermans J, Gillain S, Buckinx F, Dardenne N, Bruyère O. Validation of the SarQoL®, 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.
- Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyère 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. Erratum in: Age Ageing. 2019 Jul 1;48(4):601.
- Ignacio de Ulíbarri J, González-Madroño A, de Villar NG, González P, González B, Mancha A, Rodríguez F, Fernández G. CONUT: a tool for controlling nutritional status. First validation in a hospital population. Nutr Hosp. 2005 Jan-Feb;20(1):38-45.
- Rubio Castañeda FJ, Tomás 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. pii: e201701004. Spanish.
- FOOP-Sarc study
- PID2019-105164RB-I00