An interventional study of VOILA in Aging, sponsored by Leiden University Medical Center. Status unknown at 3 sites in Netherlands. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-29.
Sponsored by Leiden University Medical Center · Not applicable, Interventional, and Other
The multi-disciplinary and translational VOILA project presents a unique intersection between gut, immuno-metabolic, and musculoskeletal health. The main goals of the project are to develop biomarkers for healthy aging and prevent disease by maintaining quality of life in older adults. Within this umbrella project, the multimodal VOILA lifestyle intervention study will assess the impact of a twelve-week strength training and nutritional intervention in older adults with different degrees of mobility. The study will improve the current understanding of the complex relationship between gut and muscle health in different segments of mobility and obtain an insight into the heterogeneity of responsiveness between individuals.
Leiden University Medical Center is the lead sponsor of 326 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Additional group-specific criteria:
Metabolically compromised group
Reduced mobility group - People able to walk but needing walking aids to walk anywhere outside their house
Total knee replacement intervention and control group
Active reference group
Exclusion Criteria:
Specific for TKR group:
Only baseline measurements will be done.
Group with metabolomic mortality scores above threshold will undergo intervention. Baseline and endline measurements.
Combination Product: VOILA
Group with walking aids will undergo intervention. Baseline and endline measurements.
Combination Product: VOILA
Group with recent knee replacement surgery will undergo intervention. Baseline and endline measurements.
Combination Product: VOILA
Group with recent knee replacement surgery will undergo standard care. Baseline and endline measurements.
Participants will be given dietary supplement powder containing protein, galactooligosaccharide (GOS), vitamin D, and calcium throughout the twelve weeks of intervention. This will be accompanied with a resistance training regime whereby participants will train three times a week for the three months. A variety of measurements will be carried out at baseline and at endline.
Muscle mass
appendicular lean mass in kg (DEXA)
Time frame: 10 weeks
Muscle function
5-times repeated chair rise test in seconds
Time frame: 10 weeks
Gut health
bifidobacteria (from stool sample) in log10 cells per gram dried faeces
Time frame: 10 weeks
Immuno-metabolic health - GLC
fasting blood glucose (GLC) in mmol/L
Time frame: 10 weeks
Immuno-metabolic health - GlycA
glycoprotein acetyls (GlycA) in mmol/L
Time frame: 10 weeks
Immuno-metabolic health - VLDL
very low-density lipoprotein (VLDL)-diameter in nm (from Nightingale 1H NMR platform)
Time frame: 10 weeks
Muscle function - SPPB
Short Physical Performance Battery (SPPB)
Time frame: 10 weeks
Muscle function - TUG
Timed Up and Go test (TUG)
Time frame: 10 weeks
Muscle function - 6MWT
6-minute walking test (6MWT)
Time frame: 10 weeks
Muscle function - 1RM
1 repetition maximum test (1RM) as measured on exercise machines
Time frame: 10 weeks
Body composition - Whole body regional lean mass
DEXA whole body lean mass in kg
Time frame: 10 weeks
Body composition - Whole body regional fat mass
DEXA whole body fat mass in kg
Time frame: 10 weeks
Body composition - Regional lean mass
DEXA regional lean mass in kg
Time frame: 10 weeks
Body composition - Regional fat mass
DEXA regional fat mass in kg
Time frame: 10 weeks
Immuno-metabolic health - Hba1c
haemoglobin A1c (Hba1c)
Time frame: 10 weeks
Immuno-metabolic health - Insulin
Insulin in mol/L
Time frame: 10 weeks
Immuno-metabolic health - Blood pressure
Blood pressure in mmHg
Time frame: 10 weeks
Knee replacement group additional outcomes - CT
Single-slice CT-scans midway the upper legs
Time frame: 10 weeks
Knee replacement group additional outcomes - WOMAC
Western Ontario and McMaster Universities Arthritis Index (WOMAC).
Time frame: 10 weeks
Plan to share: Yes — Clinical data in this project will only be shared within the constraints of the informed consent. Furthermore for all permitted sharing, a data access committee (DAC) has been established in which the responsible PI of each center is present, a secretary and data manager. The data will primarily be analysed by the centers generating the data and associated partners in the VOILA project. In a later stage data access can be requested at the central contact person P.E. Slagboom (p.slagboom@lumc.nl ) and permitted by the DAC and analysed locally provided a data access agreement is signed.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Leiden University Medical Center