Trial in Elderly With Musculoskeletal Problems Due to Underlying Sarcopenia - Faeces to Unravel Gut and Inflammation Translationally
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Intestinal inflammation
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Intestinal inflammation
时间窗: Baseline
Markers of intestinal inflammation: fecal calprotectin, lactoferrin, S100A12
Gut microbiota composition
时间窗: Baseline
Gut microbiota composition (measured through 16S ribosomal RNA (rRNA) gene sequencing).
Systemic inflammation
时间窗: 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
次要结局
- Functional status(Baseline)
- Muscle mass (DXA)(Baseline)
- Urinary nitrogen(Baseline)
- Functional status (ADL)(Baseline)
- Physical activity(Baseline)
- Muscle strength (upper limbs)(Screening; baseline)
- Muscle strength (lower limbs)(Screening; baseline)
- Muscle mass (BIA)(Baseline)
- Cognitive status (RBANS)(Baseline)
- Physical performance(Baseline)
- Physical performance (gait speed)(Baseline)
- Dietary intake(Baseline)
- Health-related quality of life (SarQoL)(Baseline)
- Balance(Baseline)
- Health-related quality of life (SF-36)(Baseline)
- Cognitive status (MMSE)(Baseline)