Status:
UNKNOWN
The VOILA Intervention Study
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Maastricht University Medical Center
Wageningen University and Research
Conditions:
Aging
Eligibility:
All Genders
70+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
- 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\*
- 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
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT05354310
Start Date
February 1 2022
End Date
July 1 2024
Last Update
April 29 2022
Active Locations (3)
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1
Wageningen University & Research
Wageningen, Gelderland, Netherlands, 6708 WE
2
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 HX
3
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZC