Clinical trial NCT05485402: Dietary Strategy to Tackle Sarcopenia in Early Elderly Subjects (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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Keywords: early elderly
olive oil
prebiotic supplementation
muscle mass
muscle strength
physical performance
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 135
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, parallel and double-blind intervention study. The total duration of the study will be 24 weeks (12-weeks of intervention and 12-weeks of follow-up). The study will have three arms of intervention. The intervention products will be prebiotic supplement based on FOS and inulin or virgin olive oil rich in phenolic compounds with 156 mg hydroxytyrosol and tyrosol/kg oil. The placebo will be refined olive oil (38.6 mg hydroxytyrosol and tyrosol/kg oil) or maltodextrin. Both with the same format and appearance, to ensure the double-blind intervention.

All the volunteers will receive NFOC-diet and physical activity recommendations co-created during the co-creation study. The nutritional recommendations are based on DASH diet and foods rich in protein (in particular, leucine), vitamin D, polyunsaturated acids, phosphorus and iron. The physical activity recommendations are 150 min/week of physical activity, with at least two sessions focused on motor strength.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in muscle mass
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Secondary outcomes:
measure: Body-weight
timeFrame: Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
measure: Height
timeFrame: Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
measure: Body Mass Index
timeFrame: Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
measure: Body weight composition
timeFrame: Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
measure: Waist circumference
timeFrame: Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
measure: Sarcopenia assessment_skeletal muscle strength
timeFrame: Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
measure: Sarcopenia assessment_muscle mass
timeFrame: Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
measure: Sarcopenia assessment_muscle physical performance
timeFrame: Visit 0 (week -1), visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
measure: Compliance of physical activity recommendations
timeFrame: 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)
measure: Compliance of the dietary recommendations
timeFrame: 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)
measure: Dietary compliance markers
timeFrame: Visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
measure: Specific phenolic compounds_dietary compliance markers
timeFrame: Visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
measure: Phenolic metabolites_dietary compliance markers
timeFrame: Visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
measure: Sarcopenia and Quality of life
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Fasting blood glucose (FBG)
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Insulin
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Homeostasis model assessment index (HOMA index)
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Lipid profile
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Apolipoproteins
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Apolipoproteins ratio
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Vascular parameters_endothelial function
timeFrame: Visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
measure: Vascular parameters_blood pressure
timeFrame: Visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
measure: Vascular parameters_pulse pressure
timeFrame: Visit 1 (week 0), visit 3 (week 4), visit 5 (week 8), visit 7 (week 12), visit 8 (week 24)
measure: Endothelin
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Endothelial dysfunction markers
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Oxidative biomarkers_Oxidized LDL
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Oxidative biomarkers_Superoxide Dismutase
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Oxidative biomarkers_Glutathione peroxidase
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Inflammation biomarkers_High sensitivity C-reactive protein
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Inflammation biomarkers_interleukine-6
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Inflammation biomarkers_uric acid
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Inflammation biomarkers_tumour necrosis factor-α
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Renal function_creatinine
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Renal function_glomerular filtration rate
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Endocrine system
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Proteome profiling
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Gut microbiota_phyla composition and functionality
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
measure: Gut microbiota_short chain fatty acids
timeFrame: Visit 1 (week 0), visit 7 (week 12), visit 8 (week 24)
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Universitat Rovira i Virgili
state: Tarragona
Study officials:
affiliation: University Rovira i Virgili, Reus, Tarragona, Spain
name: Rosa Solà, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Rovira i Virgili, Reus, Tarragona, Spain
name: Rosa Maria Valls, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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.