Understanding the connection between saliva and muscle loss in older adults
| ISRCTN | ISRCTN18227742 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18227742 |
- Submission date
- 21/09/2024
- Registration date
- 04/10/2024
- Last edited
- 22/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Sarcopenia is a condition that involves the gradual loss of muscle mass, strength, and function. It is linked to adverse outcomes such as falls, hospitalizations, and increased risk of death. Despite its significant impact on ageing populations, effective treatments are limited due to gaps in understanding its underlying causes. While the role of the gut microbiome (bacteria) in sarcopenia has gained attention, the potential influence of other microbial ecosystems, such as the oral (mouth) microbiome, remains underexplored. This study aims to investigate the relationship between sarcopenia and the oral microbiome using a comprehensive multi-omics approach (combining different types of biological data).
Who can participate?
Caucasian older adults aged 70+ years without diseases interfering with sarcopenia
What does the study involve?
The study is conducted in three phases:
Phase 1: Analysis to link sarcopenia status (muscle mass, strength, and function) with salivary microbiome composition using multi-omics techniques.
Phase 2: Muscle tissue biopsies (samples) will be analyzed in some of the participants
Phase 3: A 2-year follow-up will track changes in sarcopenia and adverse outcomes (e.g., falls, hospitalizations), with another analysis of saliva and blood samples at the end.
What are the possible benefits and risks of participating?
Participants will gain insights into their sarcopenia status, receive personalized feedback, and have their blood analysis results shared with their physicians. For those undergoing muscle biopsies, there is a minor risk of pain, bleeding, or infection.
Where is the study run from?
Ghent University Hospital (Belgium)
When is the study starting and how long is it expected to run for?
March 2023 to December 2026
Who is funding the study?
Ghent University Hospital (Belgium)
Who is the main contact?
Dr Anton De Spiegeleer, anton.despiegeleer@uzgent.be
Contact information
Public, Scientific, Principal Investigator
Corneel Heymanslaan 10
Ghent
9000
Belgium
 ORCID ID |
0000-0002-3681-2807 |
|---|---|
| Phone | +32 (0)93328467 |
| anton.despiegeleer@uzgent.be |
Study information
| Study design | Multicenter observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Care home, Community |
| Study type | Diagnostic, Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | SaMu: an observational study on the link between salivary omics and muscle ageing (sarcopenia) |
| Study acronym | SaMu |
| Study objectives | The gut microbiome is recognized as a pivotal factor in the pathophysiology of sarcopenia, a condition marked by the accelerated loss of muscle strength, mass and function with ageing. Despite this well-known gut-muscle axis, the potential links between other microbial ecosystems and sarcopenia remain largely unexplored. The oral microbiome has been linked to various age-related health conditions such as rheumatoid arthritis and colorectal cancer. However, its potential association with sarcopenia is unknown. The Saliva and Muscle (SaMu) study seeks to address this knowledge gap. |
| Ethics approval(s) |
Approved 20/04/2023, Ghent University Hospital Ethics Committee (Corneel Heymanslaan 10, Ghent, 9000, Belgium; +32 (0)9 332 21 11; ethisch.comite@uzgent.be), ref: BC-1850-AM02 |
| Health condition(s) or problem(s) studied | Sarcopenia |
| Intervention | 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 participants aged 70+ years will be recruited from community, assisted living, and nursing home settings. The salivary microbiome will be analyzed using shotgun metagenomics, and sarcopenia will be assessed via muscle mass (bioelectrical impedance analysis, calf circumference), muscle strength (grip strength, 5-times-sit-to-stand), and physical performance (walking speed). Additional omic analyses (proteomics, metabolomics, peptidomics) and clinical variables (demographics, health status, blood parameters) will be collected. Phase 2: Mechanistic Sub-Analysis An in-depth analysis of muscle tissue (histology, genomics, transcriptomics) will be conducted on a subcohort of 50 participants (25 healthy, 25 severe sarcopenia) to investigate underlying pathways. Phase 3: Longitudinal Follow-Up A 2-year follow-up of the initial cohort will include resampling of blood and saliva, alongside tracking secondary outcomes such as falls, hospitalization, and mortality. For detailed protocols, see De Spiegeleer et al., Journal of Frailty & Aging 2024. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/03/2023 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Lower age limit | 70 Years |
| Upper age limit | 120 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Caucasian 2. Aged 70 years or older |
| Key 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 |
| Date of first enrolment | 01/05/2024 |
| Date of final enrolment | 30/04/2025 |
Locations
Countries of recruitment
- Belgium
Study participating centres
Ghent
9000
Belgium
Melle
9090
Belgium
Sponsor information
Hospital/treatment centre
Corneel Heymanslaan 10
Ghent
9000
Belgium
| Phone | +32 (0)9 332 21 11 |
|---|---|
| info@uzgent.be | |
| Website | https://www.uzgent.be/ |
"ROR" |
https://ror.org/00xmkp704 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Ghent University Hospital, UZ Gent
- Location
- Belgium
Government organisation / Local government
- Alternative name(s)
- Research Foundation Flanders, Flemish Research Foundation, FWO
- Location
- Belgium
Results and Publications
| Intention to publish date | 01/08/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publications in peer-reviewed journals. The full rationale and protocol will be published in the Journal of Frailty & Aging (https://link.springer.com/journal/42415). |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 01/11/2024 | 22/11/2024 | Yes | No |
Editorial Notes
22/11/2024: Publication reference added.
23/09/2024: Study's existence confirmed by Ghent University Hospital Ethics Committee.
