Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
220 participants
INTERVENTIONAL
2022-02-01
2024-07-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Active reference group
Only baseline measurements will be done.
No interventions assigned to this group
Metabolically compromised group
Group with metabolomic mortality scores above threshold will undergo intervention. Baseline and endline measurements.
VOILA
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.
Mobility compromised
Group with walking aids will undergo intervention. Baseline and endline measurements.
VOILA
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.
Knee replacement INT
Group with recent knee replacement surgery will undergo intervention. Baseline and endline measurements.
VOILA
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.
Knee replacement Control
Group with recent knee replacement surgery will undergo standard care. Baseline and endline measurements.
No interventions assigned to this group
Interventions
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VOILA
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.
Eligibility Criteria
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Inclusion Criteria
* 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
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
Exclusion Criteria
* 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\*
* 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
70 Years
ALL
Yes
Sponsors
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Maastricht University Medical Center
OTHER
Wageningen University and Research
OTHER
FrieslandCampina
INDUSTRY
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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P.Eline Slagboom
Professor of Molecular Epidemiology
Principal Investigators
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P. Eline Slagboom, PhD
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center
Lex Verdijk, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Lisette de Groot, PhD
Role: PRINCIPAL_INVESTIGATOR
Wageningen University & Research
Locations
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Wageningen University & Research
Wageningen, Gelderland, Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Leiden University Medical Center
Leiden, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Lisette de Groot, PhD
Role: primary
Charlotte Kramer, MSc
Role: backup
Lex Verdijk, PhD
Role: primary
Alejandra Monsegue, MSc
Role: backup
P. Eline Slagboom, PhD
Role: primary
Jordi Morwani Mangnani, MSc
Role: backup
Other Identifiers
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NL76879.058.21
Identifier Type: -
Identifier Source: org_study_id