Sarcopenia
Conditions
Keywords
gut microbiota, gut-muscle axis, healthy ageing, intestinal inflammation, systemic inflammation, gut microbiome
Brief summary
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).
Interventions
OTHERNo intervention
No intervention
Sponsors
Research Foundation Flanders
KU Leuven
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota composition | Baseline | Gut microbiota composition (measured through 16S ribosomal RNA (rRNA) gene sequencing). |
| Intestinal inflammation | Baseline | Markers of intestinal inflammation: fecal calprotectin, lactoferrin, S100A12 |
| Systemic inflammation | Baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength (lower limbs) | Screening; baseline | Chair stand test |
| Muscle mass (BIA) | Baseline | Appendicular lean mass measured with a Dual-energy X-ray absorptiometry (DXA) scan |
| Muscle mass (DXA) | Baseline | Appendicular lean mass measured with bioelectrical impedance analysis |
| Dietary intake | Baseline | Food diaries will help to evaluate dietary protein and fatty acids intake |
| Urinary nitrogen | Baseline | Urinary nitrogen |
| Functional status | Baseline | Frailty scale according to Fried et al. (2001) |
| Physical performance | Baseline | Short Physical Performance Battery (SPPB) score |
| Balance | Baseline | Mini-Balance Evaluation Systems Test (Mini-BESTest) |
| Physical activity | Baseline | Time of physical activity throughout the day measured with MoveMonitor+ |
| Health-related quality of life (SF-36) | Baseline | Measured trough the Short Form Health Questionnaire (SF-36) Quality of Life) |
| Health-related quality of life (SarQoL) | Baseline | SarQoL(Sarcopenia Quality of Life) |
| Cognitive status (MMSE) | Baseline | Mini-Mental State Exam (MMSE) |
| Cognitive status (RBANS) | Baseline | Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) |
| Functional status (ADL) | Baseline | Activities of daily living (Barthel index) |
| Physical performance (gait speed) | Baseline | gait speed (expressed in m/s) |
| Muscle strength (upper limbs) | Screening; baseline | Handgrip strength measured with Jamar dynamometer (expressed in kg) |
Countries
Belgium
Contacts
Primary ContactJolan Dupont, MD
Backup ContactLaura Vercauteren, MSc
Outcome results
None listed