Clinical trial NCT05008770: Trial in Elderly With Musculoskeletal Problems Due to Underlying Sarcopenia - Faeces to Unravel Gut and Inflammation Translationally
Official title: Trial in Elderly With Musculoskeletal Problems Due to Underlying Sarcopenia - Faeces to Unravel Gut and Inflammation Translationally
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcopenia
Keywords: gut microbiota
gut-muscle axis
healthy ageing
intestinal inflammation
systemic inflammation
gut microbiome
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
name: KU Leuven
First posted: 2021-08-17
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers (aged 65+ years) without probable, confirmed or severe sarcopenia (according to the EWGSOP2), matched according to gender, age and BMI with participants of ENHANce (NCT03649698)

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Gut microbiota composition
timeFrame: Baseline
measure: Intestinal inflammation
timeFrame: Baseline
measure: Systemic inflammation
timeFrame: Baseline
Secondary outcomes:
measure: Physical performance
timeFrame: Baseline
measure: Physical performance (gait speed)
timeFrame: Baseline
measure: Muscle strength (upper limbs)
timeFrame: Screening; baseline
measure: Muscle strength (lower limbs)
timeFrame: Screening; baseline
measure: Muscle mass (BIA)
timeFrame: Baseline
measure: Muscle mass (DXA)
timeFrame: Baseline
measure: Dietary intake
timeFrame: Baseline
measure: Urinary nitrogen
timeFrame: Baseline
measure: Functional status
timeFrame: Baseline
measure: Functional status (ADL)
timeFrame: Baseline
measure: Balance
timeFrame: Baseline
measure: Physical activity
timeFrame: Baseline
measure: Health-related quality of life (SF-36)
timeFrame: Baseline
measure: Health-related quality of life (SarQoL)
timeFrame: Baseline
measure: Cognitive status (MMSE)
timeFrame: Baseline
measure: Cognitive status (RBANS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: Gerontology and Geriatrics, Department of Public Health and Primary Care, KULeuven
name: Evelien Gielen, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: