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

NCT05008770 | Recruiting

• 2 other identifiers: s65127B32220221000449
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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).

Conditions

Sarcopenia

Keywords

gut microbiota; gut-muscle axis; healthy ageing; intestinal inflammation; systemic inflammation; gut microbiome

Outcome Measures

Primary Outcomes (3)

• Gut microbiota composition

  Gut microbiota composition (measured through 16S ribosomal RNA (rRNA) gene sequencing).

  Baseline

• Intestinal inflammation

  Markers of intestinal inflammation: fecal calprotectin, lactoferrin, S100A12

  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

  Baseline

Secondary Outcomes (16)

• Physical performance

  Baseline

• Physical performance (gait speed)

  Baseline

• Muscle strength (upper limbs)

  Screening; baseline

• Muscle strength (lower limbs)

  Screening; baseline

• Muscle mass (BIA)

  Baseline

Study Arms (1)

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

Interventions

No intervention OTHER

No intervention

Older adults without sarcopenia

Eligibility Criteria

• Age: 65 Years+
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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)

You may qualify if:

• 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
• years or older
• Community-dwelling elderly or assisted living
• Dutch speaking

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Research Foundation Flanders: collaborator
• KU Leuven: collaborator

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 37752426 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool, blood and urine samples

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Evelien Gielen, PhD MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jolan Dupont, MD

CONTACT

+32 16 34 32 01; jolan.dupont@uzleuven.be

Laura Vercauteren, MSc

CONTACT

+32 16 34 38 67; laura.vercauteren@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 17, 2021
• Study Start: September 21, 2021
• Primary Completion: December 1, 2024
• Study Completion: November 1, 2025
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

BE (1)