Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05008770
Other study ID # s65127
Secondary ID B32220221000449
Status Recruiting
Phase
First received
Last updated
Start date September 21, 2021
Est. completion date January 2024

Study information

Verified date May 2023
Source Universitaire Ziekenhuizen KU Leuven
Contact Jolan Dupont, MD
Phone +32 16 34 32 01
Email jolan.dupont@uzleuven.be
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date January 2024
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
Belgium UZ Leuven Leuven

Sponsors (3)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven KU Leuven, Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gut microbiota composition Gut microbiota composition (measured through 16S ribosomal RNA (rRNA) gene sequencing). Baseline
Primary Intestinal inflammation Markers of intestinal inflammation: fecal calprotectin, lactoferrin, S100A12 Baseline
Primary 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 Physical performance Short Physical Performance Battery (SPPB) score Baseline
Secondary Physical performance (gait speed) gait speed (expressed in m/s) Baseline
Secondary Muscle strength (upper limbs) Handgrip strength measured with Jamar dynamometer (expressed in kg) Screening; baseline
Secondary Muscle strength (lower limbs) Chair stand test Screening; baseline
Secondary Muscle mass (BIA) Appendicular lean mass measured with a Dual-energy X-ray absorptiometry (DXA) scan Baseline
Secondary Muscle mass (DXA) Appendicular lean mass measured with bioelectrical impedance analysis Baseline
Secondary Dietary intake Food diaries will help to evaluate dietary protein and fatty acids intake Baseline
Secondary Urinary nitrogen Urinary nitrogen Baseline
Secondary Functional status Frailty scale according to Fried et al. (2001) Baseline
Secondary Functional status (ADL) Activities of daily living (Barthel index) Baseline
Secondary Balance Mini-Balance Evaluation Systems Test (Mini-BESTest) Baseline
Secondary Physical activity Time of physical activity throughout the day measured with MoveMonitor+ Baseline
Secondary Health-related quality of life (SF-36) Measured trough the Short Form Health Questionnaire (SF-36) Quality of Life) Baseline
Secondary Health-related quality of life (SarQoL) SarQoL(Sarcopenia Quality of Life) Baseline
Secondary Cognitive status (MMSE) Mini-Mental State Exam (MMSE) Baseline
Secondary Cognitive status (RBANS) Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Baseline
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06287502 - Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis N/A
Recruiting NCT05063279 - RELIEF - Resistance Training for Life N/A
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Recruiting NCT06143592 - Inspiratory Muscle Training on Balance, Falls and Diaphragm Thickness in the Elderly N/A
Terminated NCT04350762 - Nutritional Supplementation in the Elderly With Weight Loss N/A
Enrolling by invitation NCT05953116 - Managing the Nutritional Needs of Older Filipino With Due Attention to Protein Nutrition and Functional Health Study N/A
Recruiting NCT04028206 - Resistance Exercise or Vibration With HMB for Sarcopenia N/A
Enrolling by invitation NCT03297632 - Improving Muscle Strength, Mass and Physical Function in Older Adults N/A
Completed NCT04015479 - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults N/A
Completed NCT03234920 - Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation After Liver Transplantation N/A
Recruiting NCT03998202 - Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Recruiting NCT04717869 - Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty
Completed NCT05497687 - Strength-building Lifestyle-integrated Intervention N/A
Completed NCT03119610 - The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity Phase 1/Phase 2
Recruiting NCT05711095 - The Anabolic Properties of Fortified Plant-based Protein in Older People N/A
Not yet recruiting NCT05860556 - Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Recruiting NCT04545268 - Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance N/A
Recruiting NCT04522609 - Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant N/A
Recruiting NCT03160326 - The QUALITY Vets Project: Muscle Quality and Kidney Disease
Active, not recruiting NCT02912130 - Exercise and Nutrition Interventions in Age-related Sarcopenia N/A