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

June 27, 2024 updated by: Universitaire Ziekenhuizen KU Leuven
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Older adults without sarcopenia
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)
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbiota composition
Time Frame: Baseline
Gut microbiota composition (measured through 16S ribosomal RNA (rRNA) gene sequencing).
Baseline
Intestinal inflammation
Time Frame: Baseline
Markers of intestinal inflammation: fecal calprotectin, lactoferrin, S100A12
Baseline
Systemic inflammation
Time Frame: 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
Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

KU Leuven
Research Foundation Flanders

Investigators

  • Principal Investigator: Evelien Gielen, PhD MD, Gerontology and Geriatrics, Department of Public Health and Primary Care, KULeuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

August 16, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

June 28, 2024

Last Update Submitted That Met QC Criteria

June 27, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s65127
  • B32220221000449 (Registry Identifier: Belg. Regnr.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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