Trial in Elderly With Musculoskeletal Problems Due to Underlying Sarcopenia - Faeces to Unravel Gut and Inflammation Translationally

Study Overview
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Brief Summary
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The overall aim of the TEMPUS-FUGIT study is to assess gut microbiota composition in older persons without sarcopenia and to determine the relationship with and between intestinal and systemic inflammation and with sarcopenia-defining parameters (muscle mass, muscle strength and physical performance). The gut microbiota of older persons without sarcopenia (included in TEMPUS-FUGIT) will be compared with the gut microbiota of older people with sarcopenia, participating in the Exercise and Nutrition for Healthy AgeiNg (ENHANce) study (NCT03649698).

Official Title
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Trial in Elderly With Musculoskeletal Problems Due to Underlying Sarcopenia - Faeces to Unravel Gut and Inflammation Translationally

Conditions
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Sarcopenia

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female persons without probable, confirmed or severe sarcopenia according to the European Working Group on Sarcopenia in Older People (EWGSOP2): no reduced muscle strength measured by chair stand test or hand grips strength 65 years or older Community-dwelling elderly or assisted living Dutch speaking Exclusion Criteria: Impairments/diseases that affect performance of daily activities Persons who are systematically physically active (e.g. routine or organized sports activities) or who followed a physical activity training program (e.g., rehabilitation program) in the last 6 months (systematically = twice or more/week) Diagnosis of diabetes mellitus, measured by fasting glucose ≥126 mg/dL or HbA1C ≥ 6.5% at screening or in recent (maximum 3 months old) lab report Use of antibiotics in the last 3 months Gastrointestinal cancer (active or treated in the last 5 years) No freezer at home available After the screening visit, included persons will be invited for a test visit.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Older adults without sarcopenia<br>Healthy volunteers aged 65+ years who do not fulfill diagnostic criteria for sarcopenia, according to the revised European Working Group on Sarcopenia in Older People (EWGSOP2) | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiota composition | Gut microbiota composition (measured through 16S ribosomal RNA (rRNA) gene sequencing). | Baseline | 
| Intestinal inflammation | Markers of intestinal inflammation: fecal calprotectin, lactoferrin, S100A12 | Baseline | 
| Systemic inflammation | Markers of inflammation in blood samples: C reactive protein (hs-CRP), sedimentation rate, Interleukin 6 (IL-6), IL-4, IL-13, IL-1b, Tumor necrosis factor alpha | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical performance | Short Physical Performance Battery (SPPB) score | Baseline | 
| Physical performance (gait speed) | gait speed (expressed in m/s) | Baseline | 
| Muscle strength (upper limbs) | Handgrip strength measured with Jamar dynamometer (expressed in kg) | Screening; baseline | 
| Muscle strength (lower limbs) | Chair stand test | Screening; baseline | 
| Muscle mass (BIA) | Appendicular lean mass measured with a Dual-energy X-ray absorptiometry (DXA) scan | Baseline | 
| Muscle mass (DXA) | Appendicular lean mass measured with bioelectrical impedance analysis | Baseline | 
| Dietary intake | Food diaries will help to evaluate dietary protein and fatty acids intake | Baseline | 
| Urinary nitrogen | Urinary nitrogen | Baseline | 
| Functional status | Frailty scale according to Fried et al. (2001) | Baseline | 
| Functional status (ADL) | Activities of daily living (Barthel index) | Baseline | 
| Balance | Mini-Balance Evaluation Systems Test (Mini-BESTest) | Baseline | 
| Physical activity | Time of physical activity throughout the day measured with MoveMonitor+ | Baseline | 
| Health-related quality of life (SF-36) | Measured trough the Short Form Health Questionnaire (SF-36) Quality of Life) | Baseline | 
| Health-related quality of life (SarQoL) | SarQoL(Sarcopenia Quality of Life) | Baseline | 
| Cognitive status (MMSE) | Mini-Mental State Exam (MMSE) | Baseline | 
| Cognitive status (RBANS) | Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gut microbiota, gut-muscle axis, healthy ageing, intestinal inflammation, systemic inflammation, gut microbiome