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AgingVOILANCT05354310

The VOILA Intervention Study

A study testing VOILA in people with Aging, run by Leiden University Medical Center at 3 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 70 years and olderHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
VOILA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
3 sitesNetherlands
Study dates
1 Feb 2022to 1 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Age ≥70 years
  • A body mass index of 18.5-35.0 kg/m2
  • Able to give written informed consent
  • Community-dwelling
  • Mentally competent with a Mini-Mental State Examination (MMSE) score of ≥24 points
  • Able to follow the study protocol
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  • Additional group-specific criteria:
  • Metabolically compromised group
  • Framingham Risk Score ≥14 and Metabolomic Mortality Score of ≥0.173
  • Reduced mobility group - People able to walk but needing walking aids to walk anywhere outside their house
  • Total knee replacement intervention and control group
  • Discharged from MUMC+ after undergoing elective knee replacement surgery (intervention starts ~4 weeks after surgery)
  • Active reference group
  • People who meet the "Nederlandse Norm Gezond Bewegen". This means they partake in at least moderate exercise for at least 30 minutes on 5 days of the week, as determined by the SQUASH questionnaire (40).
  • Framingham Risk Score of <14 and Metabolic Mortality Score of <0.173

Who cannot join

  • Already using prebiotic fibres*
  • Use of laxatives*
  • Not willing to stop using dietary supplements in high doses (high doses: 0.10*Upper Level or more)*
  • Following a structured, intense exercise programme (currently or in the last year)*
  • Allergic, intolerant or hypersensitive to milk/lactose (self-reported)*
  • Dietary restrictions on milk/lactose/prebiotics/vitamin D/calcium consumption*
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  • Abnormal hepatic or renal laboratory parameters (estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2 (screening) or contra-indication by treating medical practitioner (data from hospital)
  • Diagnosis of disorders/diseases in which a high protein intake can be harmful, such as renal impairment or failure, liver disease, or diabetes associated with nephropathy (treating medical practitioner has the decisive voice).
  • Diseases, conditions or disorders which may affect the ability to follow the study protocol and which cannot be overcome with help of a caregiver Any other medical condition that may interfere with the safety of the participants during training or assessment of the outcome parameters, in the investigators' judgement
  • Current participation in other scientific research that conflicts with this study (e.g. intervention studies or weight management studies)
  • Not signed up to a general practitioner
  • No permission to request information from the general practitioner/ treating specialist(s) about medical history, medication use.
  • Specific for TKR group:
  • Referral to rehabilitation facility after hospital discharge
  • Osteoarthritis of the knee secondary to septic arthritis, osteonecrosis, fracture, osteochondritis dissecans, or malignant processes
  • Collagen disorders, e.g. Marfan and Ehler-Danlos
  • Total hip prosthesis or TKR in both legs

Trial locations and contacts

3 sites in 1 country.

P. Eline Slagboom, PhD contact

0653879941 ext. 31

P.Slagboom@lumc.nl

Jordi Morwani Mangnani, MSc contact

j.morwani_mangnani@lumc.nl

Netherlands3 sites, 3 recruiting

  • Leiden University Medical Center

    Leiden, South Holland, 2333 ZC

    P. Eline Slagboom, PhD, j.morwani_mangnani@lumc.nl

    Jordi Morwani Mangnani, MSc, j.morwani_mangnani@lumc.nl

    Recruiting

  • Maastricht University Medical Center

    Maastricht, Limburg, 6229 HX

    Lex Verdijk, PhD, lex.verdijk@maastrichtuniversity.nl

    Alejandra Monsegue, MSc, a.monsegue@maastrichtuniversity.nl

    Recruiting

  • Wageningen University & Research

    Wageningen, Gelderland, 6708 WE

    Lisette de Groot, PhD, lisette.degroot@wur.nl

    Charlotte Kramer, MSc, charlotte.kramer@wur.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Vitality Oriented Innovation for the Lifecourse of the Ageing Society Intervention Study

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.

Conditions
Aging
Being tested
VOILA
Keywords
Resistance Training, Nutrition, Protein supplement, Gut microbiome, Immunometabolsim, Mobility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VOILACombination product

    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.

Study groups in NCT05354310
Study groupRoleWhat they receive
Active reference groupNo interventionOnly baseline measurements will be done.
Metabolically compromised groupExperimentalGroup with metabolomic mortality scores above threshold will undergo intervention. Baseline and endline measurements.
Receives: Combination Product: VOILA
Mobility compromisedExperimentalGroup with walking aids will undergo intervention. Baseline and endline measurements.
Receives: Combination Product: VOILA
Knee replacement INTExperimentalGroup with recent knee replacement surgery will undergo intervention. Baseline and endline measurements.
Receives: Combination Product: VOILA
Knee replacement ControlNo interventionGroup with recent knee replacement surgery will undergo standard care. Baseline and endline measurements.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle mass

    appendicular lean mass in kg (DEXA)

    Measured: 10 weeks

  2. Muscle function

    5-times repeated chair rise test in seconds

    Measured: 10 weeks

  3. Gut health

    bifidobacteria (from stool sample) in log10 cells per gram dried faeces

    Measured: 10 weeks

  4. Immuno-metabolic health - GLC

    fasting blood glucose (GLC) in mmol/L

    Measured: 10 weeks

  5. Immuno-metabolic health - GlycA

    glycoprotein acetyls (GlycA) in mmol/L

    Measured: 10 weeks

  6. Immuno-metabolic health - VLDL

    very low-density lipoprotein (VLDL)-diameter in nm (from Nightingale 1H NMR platform)

    Measured: 10 weeks

Secondary outcomes (13)

  1. Muscle function - SPPB

    Short Physical Performance Battery (SPPB)

    Measured: 10 weeks

  2. Muscle function - TUG

    Timed Up and Go test (TUG)

    Measured: 10 weeks

  3. Muscle function - 6MWT

    6-minute walking test (6MWT)

    Measured: 10 weeks

  4. Muscle function - 1RM

    1 repetition maximum test (1RM) as measured on exercise machines

    Measured: 10 weeks

  5. Body composition - Whole body regional lean mass

    DEXA whole body lean mass in kg

    Measured: 10 weeks

  6. Body composition - Whole body regional fat mass

    DEXA whole body fat mass in kg

    Measured: 10 weeks

  7. Body composition - Regional lean mass

    DEXA regional lean mass in kg

    Measured: 10 weeks

  8. Body composition - Regional fat mass

    DEXA regional fat mass in kg

    Measured: 10 weeks

  9. Immuno-metabolic health - Hba1c

    haemoglobin A1c (Hba1c)

    Measured: 10 weeks

  10. Immuno-metabolic health - Insulin

    Insulin in mol/L

    Measured: 10 weeks

  11. Immuno-metabolic health - Blood pressure

    Blood pressure in mmHg

    Measured: 10 weeks

  12. Knee replacement group additional outcomes - CT

    Single-slice CT-scans midway the upper legs

    Measured: 10 weeks

  13. Knee replacement group additional outcomes - WOMAC

    Western Ontario and McMaster Universities Arthritis Index (WOMAC).

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2022
  2. Study start1 Feb 2022
  3. Primary completion1 Feb 2024 (estimated)
  4. Study completion1 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05354310
Sponsor's protocol ID
NL76879.058.21
Acronym
VOILA
Status last verified
Apr 2022
First submitted
15 Apr 2022
Last updated
29 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Monsegue AP, Wilms EJC, Kramer CS, Morwani-Magnani J, VAN DER Haijden M, Singh-Povel CM, Grootswagers P, DE Groot LCPGM, Slagboom PE, VAN Loon LJC, Verdijk LB. High-Intensity Resistance Training Enhances Strength, But Not Muscle Mass and Physical Functioning Gains during Total Knee Arthroplasty Rehabilitation. Med Sci Sports Exerc. 2026 Aug 1;58(8):1651-1663. doi: 10.1249/MSS.0000000000004003. Epub 2026 Apr 7.

    PubMed 42008941

Questions about this trial

What is this clinical trial studying?

A study testing VOILA in people with Aging, run by Leiden University Medical Center at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact P. Eline Slagboom, PhD (0653879941 ext. 31, P.Slagboom@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle mass (time frame: 10 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05354310, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022; AzTrials last refreshed its copy on 3 Nov 2026.

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