The VOILA Intervention Study
- Conditions
- Aging
- Interventions
- Combination Product: VOILA
- Registration Number
- NCT05354310
- Lead Sponsor
- Leiden University Medical Center
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 220
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Knee replacement INT VOILA Group with recent knee replacement surgery will undergo intervention. Baseline and endline measurements. Mobility compromised VOILA Group with walking aids will undergo intervention. Baseline and endline measurements. Metabolically compromised group VOILA Group with metabolomic mortality scores above threshold will undergo intervention. Baseline and endline measurements.
- Primary Outcome Measures
Name Time Method Immuno-metabolic health - GLC 10 weeks fasting blood glucose (GLC) in mmol/L
Gut health 10 weeks bifidobacteria (from stool sample) in log10 cells per gram dried faeces
Muscle mass 10 weeks appendicular lean mass in kg (DEXA)
Muscle function 10 weeks 5-times repeated chair rise test in seconds
Immuno-metabolic health - VLDL 10 weeks very low-density lipoprotein (VLDL)-diameter in nm (from Nightingale 1H NMR platform)
Immuno-metabolic health - GlycA 10 weeks glycoprotein acetyls (GlycA) in mmol/L
- Secondary Outcome Measures
Name Time Method Muscle function - 6MWT 10 weeks 6-minute walking test (6MWT)
Body composition - Whole body regional lean mass 10 weeks DEXA whole body lean mass in kg
Knee replacement group additional outcomes - WOMAC 10 weeks Western Ontario and McMaster Universities Arthritis Index (WOMAC).
Immuno-metabolic health - Insulin 10 weeks Insulin in mol/L
Muscle function - 1RM 10 weeks 1 repetition maximum test (1RM) as measured on exercise machines
Knee replacement group additional outcomes - CT 10 weeks Single-slice CT-scans midway the upper legs
Muscle function - SPPB 10 weeks Short Physical Performance Battery (SPPB)
Muscle function - TUG 10 weeks Timed Up and Go test (TUG)
Body composition - Whole body regional fat mass 10 weeks DEXA whole body fat mass in kg
Body composition - Regional lean mass 10 weeks DEXA regional lean mass in kg
Body composition - Regional fat mass 10 weeks DEXA regional fat mass in kg
Immuno-metabolic health - Hba1c 10 weeks haemoglobin A1c (Hba1c)
Immuno-metabolic health - Blood pressure 10 weeks Blood pressure in mmHg
Trial Locations
- Locations (3)
Wageningen University & Research
🇳🇱Wageningen, Gelderland, Netherlands
Maastricht University Medical Center
🇳🇱Maastricht, Limburg, Netherlands
Leiden University Medical Center
🇳🇱Leiden, South Holland, Netherlands