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

NCT ID: NCT05008770

Last Updated: 2024-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-21

Study Completion Date

2025-11-30

Brief Summary

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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).

Detailed Description

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Conditions

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Sarcopenia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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)

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Research Foundation Flanders

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Evelien Gielen, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Gerontology and Geriatrics, Department of Public Health and Primary Care, KULeuven

Locations

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UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Jolan Dupont, MD

Role: CONTACT

+32 16 34 32 01

Laura Vercauteren, MSc

Role: CONTACT

+32 16 34 38 67

Facility Contacts

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Laura Vercauteren, MSc

Role: primary

+3216343867

Jolan Dupont, MD

Role: backup

+3216343201

References

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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.

Reference Type DERIVED
PMID: 37752426 (View on PubMed)

Other Identifiers

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B32220221000449

Identifier Type: REGISTRY

Identifier Source: secondary_id

s65127

Identifier Type: -

Identifier Source: org_study_id

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