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

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Sarcopenia

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05008770

B32220221000449 (Registry Identifier)

s65127

Details and patient eligibility

About

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).

Enrollment: 110 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

110 participants in 1 patient group

Older adults without sarcopenia

Description:

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)

Treatment:

Other: No intervention