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Understanding the connection between saliva and muscle loss in older adults

SaMu: an observational study on the link between salivary omics and muscle ageing (sarcopenia)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN18227742
Enrollment
200
Registered
2024-10-04
Start date
2024-05-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia Musculoskeletal Diseases

Interventions

The SaMu study consists of three phases aimed at exploring the relationship between the salivary microbiome and sarcopenia in older adults. Phase 1: Cross-Sectional Analysis A cohort of 200 participa

Sponsors

Ghent University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Caucasian 2. Aged 70 years or older

Exclusion criteria

Exclusion criteria: 1. Known presence of interfering neuromuscular or osteoskeletal conditions (possibly leading to false-positive diagnosis of sarcopenia), such as stroke without full recuperation, Parkinson’s disease, spinal compression, or functional anomaly of the hands or legs 2. >10% total body weight loss over the past 6 months 3. Active malignant neoplasia 4. Status post radiation therapy in the head-neck region 5. Exposure to immunosuppressive drugs in the last 3 months before the screening visit 6. Exposure to systemic corticosteroid treatment in the last 14 days before the screening visit 7. Infection(s) requiring treatment with systemic antibiotics/antivirals/antifungals within 30 days prior to the biosampling 8. Clinically detectable active infection (e.g. respiratory or gastro-intestinal) 9. Not deeming competent to make decisions regarding their own well-being due to advanced cognitive impairment or severe psychiatric disease

Design outcomes

Primary

MeasureTime frame
Sarcopenia status is evaluated at baseline, as well as after 1 and 2 years. This status is treated as a continuous desirability variable, which is determined by three key components: muscle mass (assessed using bioelectrical impedance analysis), muscle strength (measured through grip dynamometry), and physical performance (evaluated through usual walking speed).

Secondary

MeasureTime frame
1. Sarcopenia status assessed using European Working Group On Sarcopenia in Older People 2 (EWGSOP2) criteria at baseline, as well as after 1 and 2 years 2. Individual sarcopenia components: muscle mass (assessed via bioelectrical impedance analysis), muscle strength (measured through grip dynamometry), and physical performance (evaluated by usual walking speed) assessed at baseline, 1 year, and 2 years 3. Muscle mass and strength measured through calf circumference 5-times sit-to-stand test at baseline, 1 year, and 2 years 4. Mortality determined through health record reviews and hetero-anamnesis at 1 year and 2 years 5. The number of hospitalisations identified via health record checks and hetero-anamnesis at 1 year and 2 years 6. Quality of life assessed using the SarQoL questionnaire at baseline, 1 year, and 2 years 7. The number of falls recorded through anamnesis and health record checks at 1 year and 2 years 8. The number of fractures tracked via anamnesis and health record checks at 1 year and 2 years 9. The incidence of institutionalisation determined through anamnesis and hetero-anamnesis at 1 year and 2 years

Countries

Belgium

Contacts

Public ContactAnton De Spiegeleer
anton.despiegeleer@uzgent.be+32 (0)93328467

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026