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

Universitaire Ziekenhuizen KU Leuven110 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

110

Conditions

Sarcopenia

Interventions

No interventionOTHER

No intervention

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Gut microbiota composition

Gut microbiota composition (measured through 16S ribosomal RNA (rRNA) gene sequencing).

Time frame: Baseline

Intestinal inflammation

Markers of intestinal inflammation: fecal calprotectin, lactoferrin, S100A12

Time frame: 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

Time frame: Baseline

Secondary Outcomes

Physical performance

Short Physical Performance Battery (SPPB) score

Time frame: Baseline

Physical performance (gait speed)

gait speed (expressed in m/s)

Time frame: Baseline

Muscle strength (upper limbs)

Handgrip strength measured with Jamar dynamometer (expressed in kg)

Time frame: Screening; baseline

Muscle strength (lower limbs)

Chair stand test

Time frame: Screening; baseline

Muscle mass (BIA)

Appendicular lean mass measured with a Dual-energy X-ray absorptiometry (DXA) scan

Time frame: Baseline

Muscle mass (DXA)

Appendicular lean mass measured with bioelectrical impedance analysis

Time frame: Baseline

Dietary intake

Food diaries will help to evaluate dietary protein and fatty acids intake

Time frame: Baseline

Urinary nitrogen

Time frame: Baseline

Functional status

Frailty scale according to Fried et al. (2001)

Time frame: Baseline

Functional status (ADL)

Activities of daily living (Barthel index)

Time frame: Baseline

Balance

Mini-Balance Evaluation Systems Test (Mini-BESTest)

Time frame: Baseline

Physical activity

Time of physical activity throughout the day measured with MoveMonitor+

Time frame: Baseline

Health-related quality of life (SF-36)

Measured trough the Short Form Health Questionnaire (SF-36) Quality of Life)

Time frame: Baseline

Health-related quality of life (SarQoL)

SarQoL(Sarcopenia Quality of Life)

Time frame: Baseline

Cognitive status (MMSE)

Mini-Mental State Exam (MMSE)

Time frame: Baseline

Cognitive status (RBANS)

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Time frame: Baseline

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts