Dietary Strategy to Tackle Sarcopenia in Early Elderly Subjects (FOOP-Sarc)

Sarcopenia Clinical Trial

— FOOP-Sarc  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05485402
• Other study ID #: FOOP-Sarc study
• Secondary ID: PID2019-105164RB
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: May 2024

Study information

• Verified date: May 2023
• Source: University Rovira i Virgili
• Contact: Rosa Solà, Dr
• Phone: 0034 977 75 9369
• Email: rosa.sola[@]urv.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: May 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• 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).
• 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).
• Maltodextrin
The dosage will be 7,5 g/day of maltodextrin.
• 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.

Locations

Country	Name	City	State
Spain	Universitat Rovira i Virgili	Reus	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
University Rovira i Virgili

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Beaudart 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. — View Citation

Cruz-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. Erratum In: Age Ageing. 2019 Jul 1;48(4):601. — View Citation

Ignacio 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle mass	The change in muscle mass will be assessed by Magnetic Nuclear Resonance (MNR) measured lumbar 3rd vertebra.	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	Body-weight	Measured with calibrated scale in kg	Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
Secondary	Height	Measured with wall-mounted stadiometer in cm	Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
Secondary	Body Mass Index	Calculated by weight (kg) divided to height (m2)	Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
Secondary	Body weight composition	Measured by bioimpedance (Tanita SC 330-S)	Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
Secondary	Waist circumference	Steel measuring tape at the umbilicus in cm.	Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
Secondary	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)	Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
Secondary	Sarcopenia assessment_muscle mass	Muscle mass, wasting and turnover: assessed by Magnetic Nuclear Resonance (MNR) measured lumbar 3rd vertebra	Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
Secondary	Sarcopenia assessment_muscle physical performance	Gait speed, m/s: length of the walking course divided by the time	Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
Secondary	Compliance of physical activity recommendations	IPAQ-E Spanish version	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)
Secondary	Compliance of the dietary recommendations	Dietary record: 3-day dietary record	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)
Secondary	Dietary compliance markers	Folin-Ciocalteau method adjusted by creatinine values, measured in 24h urine samples	Visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
Secondary	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	Visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
Secondary	Phenolic metabolites_dietary compliance markers	Phenolic metabolites by UPLC-MS/MS in plasma	Visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
Secondary	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.	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	Fasting blood glucose (FBG)	by standardized methods in an automated analyzer (Beckman Coulter-Synchron, Galway, Ireland) in (mmol/L)	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	Insulin	by standardized methods in an automated analyzer (Beckman Coulter-Synchron, Galway, Ireland) in (IU/mL)	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	Homeostasis model assessment index (HOMA index)	Calculated by fasting insulin (µUI/mL) x fasting glucose (mmol/L) / 22,5	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	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)	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	Apolipoproteins	Apolipoprotein A1 (ApoA1) and apolipoprotein B100 (ApoB100) in mg/dL by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland)	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	Apolipoproteins ratio	Calculated by ApoA1 divided to ApoB100	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	Vascular parameters_endothelial function	Ischemic reactive hyperemia (IRH) with Laser-Doppler Linear Periflux 5000 (Perimed AB, Järfälla, Stockholm, Sweden)	Visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
Secondary	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).	Visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
Secondary	Vascular parameters_pulse pressure	Calculated by SBP - DBP	Visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
Secondary	Endothelin	Endothelin in pg/mL assessed by Commercial ELISA	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	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.	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	Oxidative biomarkers_Oxidized LDL	Oxidized LDL (oxLDL) assessed by commercial ELISA.	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	Oxidative biomarkers_Superoxide Dismutase	Superoxide Dismutase (SOD) in U/g Hb assessed by enzymatic assay	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	Oxidative biomarkers_Glutathione peroxidase	Glutathione peroxidase (GSHPx) in nmol/mL assessed by enzymatic assay	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	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)	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	Inflammation biomarkers_interleukine-6	Interleukine-6 (IL-6) in pg/mL assessed by Immunoturbidimetry on an autoanalyzer (Roche Diagnostics Systems, Madrid, Spain)	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	Inflammation biomarkers_uric acid	Uric acid in mg/dL is assessed by Immunoturbidimetry on an autoanalyzer (Roche Diagnostics Systems, Madrid, Spain)	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	Inflammation biomarkers_tumour necrosis factor-a	Tumour necrosis factor-a (TNF-a) in pg/mL is assessed by commercial ELISA kit.	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	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	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	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).	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	Endocrine system	Testosterone (pg/mL) and growth hormone (GH) (pg/mL)) assessed by in a Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain)	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	Proteome profiling	Whole proteome assessed by nano Liquid chromatography-mass spectrometry (nLC-MS) according to our previous work.	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	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)).	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary	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)	Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)