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

Sarcopenia Clinical Trial

— TEMPUS-FUGIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05008770
• Other study ID #: s65127
• Secondary ID: B32220221000449
• Status: Recruiting
• Start date: September 21, 2021
• Est. completion date: January 2024

Study information

• Verified date: May 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Jolan Dupont, MD
• Phone: +32 16 34 32 01
• Email: jolan.dupont[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Sarcopenia

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (3)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	KU Leuven, Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiota composition	Gut microbiota composition (measured through 16S ribosomal RNA (rRNA) gene sequencing).	Baseline
Primary	Intestinal inflammation	Markers of intestinal inflammation: fecal calprotectin, lactoferrin, S100A12	Baseline
Primary	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
Secondary	Physical performance	Short Physical Performance Battery (SPPB) score	Baseline
Secondary	Physical performance (gait speed)	gait speed (expressed in m/s)	Baseline
Secondary	Muscle strength (upper limbs)	Handgrip strength measured with Jamar dynamometer (expressed in kg)	Screening; baseline
Secondary	Muscle strength (lower limbs)	Chair stand test	Screening; baseline
Secondary	Muscle mass (BIA)	Appendicular lean mass measured with a Dual-energy X-ray absorptiometry (DXA) scan	Baseline
Secondary	Muscle mass (DXA)	Appendicular lean mass measured with bioelectrical impedance analysis	Baseline
Secondary	Dietary intake	Food diaries will help to evaluate dietary protein and fatty acids intake	Baseline
Secondary	Urinary nitrogen	Urinary nitrogen	Baseline
Secondary	Functional status	Frailty scale according to Fried et al. (2001)	Baseline
Secondary	Functional status (ADL)	Activities of daily living (Barthel index)	Baseline
Secondary	Balance	Mini-Balance Evaluation Systems Test (Mini-BESTest)	Baseline
Secondary	Physical activity	Time of physical activity throughout the day measured with MoveMonitor+	Baseline
Secondary	Health-related quality of life (SF-36)	Measured trough the Short Form Health Questionnaire (SF-36) Quality of Life)	Baseline
Secondary	Health-related quality of life (SarQoL)	SarQoL(Sarcopenia Quality of Life)	Baseline
Secondary	Cognitive status (MMSE)	Mini-Mental State Exam (MMSE)	Baseline
Secondary	Cognitive status (RBANS)	Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	Baseline