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| ID | Type | Description | Link |
|---|---|---|---|
| B32220221000449 | Registry Identifier | Belg. Regnr. |
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| Name | Class |
|---|---|
| Research Foundation Flanders | OTHER |
| KU Leuven | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Older adults without sarcopenia | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical performance | Short Physical Performance Battery (SPPB) score | Baseline |
| Physical performance (gait speed) | gait speed (expressed in m/s) |
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Inclusion Criteria:
Exclusion Criteria:
After the screening visit, included persons will be invited for a test visit.
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Healthy volunteers (aged 65+ years) without probable, confirmed or severe sarcopenia (according to the EWGSOP2), matched according to gender, age and BMI with participants of ENHANce (NCT03649698)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jolan Dupont, MD | Contact | +32 16 34 32 01 | jolan.dupont@uzleuven.be | |
| Laura Vercauteren, MSc | Contact | +32 16 34 38 67 | laura.vercauteren@kuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Evelien Gielen, PhD MD | Gerontology and Geriatrics, Department of Public Health and Primary Care, KULeuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37752426 | Derived | Lapauw L, Dupont J, Amini N, Vercauteren L, Verschueren S, Tournoy J, Raes J, Gielen E. Trial in Elderly with Musculoskeletal Problems due to Underlying Sarcopenia-Faeces to Unravel the Gut and Inflammation Translationally (TEMPUS-FUGIT): protocol of a cross-sequential study to explore the gut-muscle axis in the development and treatment of sarcopenia in community-dwelling older adults. BMC Geriatr. 2023 Sep 26;23(1):599. doi: 10.1186/s12877-023-04291-5. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 23, 2026 |
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Stool, blood and urine samples
| 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 |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |