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

Recruiting

• Conditions: Sarcopenia
• Interventions: Other: No intervention

• Registration Number: NCT05008770
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-08-16
• Study First Posted: 2021-08-17
• Study Start: 2021-09-21
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28
• Primary Completion: 2024-12
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Older adults without sarcopenia	No intervention	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium