SarcopeniaTEMPUS-FUGITNCT05008770
Trial in Elderly With Musculoskeletal Problems Due to Underlying Sarcopenia - Faeces to Unravel Gut and Inflammation Translationally
An observational study of Sarcopenia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- How many people
- 110 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Sep 2021to Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Laura Vercauteren, MSc, +3216343867, laura.vercauteren@kuleuven.be
Jolan Dupont, MD, +3216343201, jolan.dupont@uzleuven.be
About this study
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).
- Conditions
- Sarcopenia
- Being tested
- No intervention
- Keywords
- gut microbiota, gut-muscle axis, healthy ageing, intestinal inflammation, systemic inflammation, gut microbiome
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota composition
Gut microbiota composition (measured through 16S ribosomal RNA (rRNA) gene sequencing).
Measured: Baseline
Intestinal inflammation
Markers of intestinal inflammation: fecal calprotectin, lactoferrin, S100A12
Measured: Baseline
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
Measured: Baseline
Secondary outcomes (16)
Physical performance
Short Physical Performance Battery (SPPB) score
Measured: Baseline
Physical performance (gait speed)
gait speed (expressed in m/s)
Measured: Baseline
Muscle strength (upper limbs)
Handgrip strength measured with Jamar dynamometer (expressed in kg)
Measured: Screening; baseline
Muscle strength (lower limbs)
Chair stand test
Measured: Screening; baseline
Muscle mass (BIA)
Appendicular lean mass measured with a Dual-energy X-ray absorptiometry (DXA) scan
Measured: Baseline
Muscle mass (DXA)
Appendicular lean mass measured with bioelectrical impedance analysis
Measured: Baseline
Dietary intake
Food diaries will help to evaluate dietary protein and fatty acids intake
Measured: Baseline
Urinary nitrogen
Urinary nitrogen
Measured: Baseline
Functional status
Frailty scale according to Fried et al. (2001)
Measured: Baseline
Functional status (ADL)
Activities of daily living (Barthel index)
Measured: Baseline
Balance
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Measured: Baseline
Physical activity
Time of physical activity throughout the day measured with MoveMonitor+
Measured: Baseline
Health-related quality of life (SF-36)
Measured trough the Short Form Health Questionnaire (SF-36) Quality of Life)
Measured: Baseline
Health-related quality of life (SarQoL)
SarQoL(Sarcopenia Quality of Life)
Measured: Baseline
Cognitive status (MMSE)
Mini-Mental State Exam (MMSE)
Measured: Baseline
Cognitive status (RBANS)
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start21 Sep 2021
- Primary completionDec 2024 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders, KU Leuven
- Responsible party
- Sponsor
- Investigators
- Evelien Gielen, PhD MD, Principal investigator, Gerontology and Geriatrics, Department of Public Health and Primary Care, KULeuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008770
- Sponsor's protocol ID
- s65127
- Other IDs
- B32220221000449
- Acronym
- TEMPUS-FUGIT
- Status last verified
- Jun 2024
- First submitted
- 28 Jul 2021
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lapauw L, Dupont J, Amini N, Vercauteren L, Verschueren S, Tournoy J, Raes J, Gielen E. Trial in Elderly with Musculoskeletal Problems due to Underlying Sarcopenia-Faeces to Unravel the Gut and Inflammation Translationally (TEMPUS-FUGIT): protocol of a cross-sequential study to explore the gut-muscle axis in the development and treatment of sarcopenia in community-dwelling older adults. BMC Geriatr. 2023 Sep 26;23(1):599. doi: 10.1186/s12877-023-04291-5.
PubMed 37752426
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial in Elderly With Musculoskeletal Problems Due to Underlying Sarcopenia - Faeces to Unravel Gut and Inflammation Translationally
- ClinicalTrials.gov ID
- NCT05008770
- Acronym / sponsor ID
- TEMPUS-FUGIT / s65127
- Conditions
- Sarcopenia
- Keywords
- gut microbiota, gut-muscle axis, healthy ageing, intestinal inflammation, systemic inflammation, gut microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Research Foundation Flanders, KU Leuven
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults without sarcopenia | – | Other: No interventionHealthy 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) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Older adults without sarcopenia |
Primary outcome
Gut microbiota composition
Time frame: Baseline
Gut microbiota composition (measured through 16S ribosomal RNA (rRNA) gene sequencing).
Intestinal inflammation
Time frame: Baseline
Markers of intestinal inflammation: fecal calprotectin, lactoferrin, S100A12
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
16 secondary outcomes
Physical performance
Time frame: Baseline
Physical performance (gait speed)
Time frame: Baseline
Muscle strength (upper limbs)
Time frame: Screening; baseline
Muscle strength (lower limbs)
Time frame: Screening; baseline
Muscle mass (BIA)
Time frame: Baseline
Muscle mass (DXA)
Time frame: Baseline
Dietary intake
Time frame: Baseline
Urinary nitrogen
Time frame: Baseline
Functional status
Time frame: Baseline
Functional status (ADL)
Time frame: Baseline
Balance
Time frame: Baseline
Physical activity
Time frame: Baseline
Health-related quality of life (SF-36)
Time frame: Baseline
Health-related quality of life (SarQoL)
Time frame: Baseline
Cognitive status (MMSE)
Time frame: Baseline
Cognitive status (RBANS)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Derived from this study: PubMed 37752426Lapauw L, Dupont J, Amini N, Vercauteren L, Verschueren S, Tournoy J, Raes J, Gielen E. Trial in Elderly with Musculoskeletal Problems due to Underlying Sarcopenia-Faeces to Unravel the Gut and Inflammation Translationally (TEMPUS-FUGIT): protocol of a cross-sequential study to explore the gut-muscle axis in the development and treatment of sarcopenia in community-dwelling older adults. BMC Geriatr. 2023 Sep 26;23(1):599. doi: 10.1186/s12877-023-04291-5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evelien Gielen, PhD MD principal investigator
Gerontology and Geriatrics, Department of Public Health and Primary Care, KULeuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jolan Dupont, MD (+32 16 34 32 01, jolan.dupont@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota composition (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05008770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.