The VOILA Intervention Study

Leiden University Medical Center (LUMC)

Status: Enrolling

Conditions: Aging

Treatments: Combination Product: VOILA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05354310

NL76879.058.21

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 5 patient groups

Active reference group

No Intervention group

Description:

Only baseline measurements will be done.

Metabolically compromised group

Experimental group

Description:

Group with metabolomic mortality scores above threshold will undergo intervention. Baseline and endline measurements.

Treatment:

Combination Product: VOILA

Mobility compromised

Experimental group

Description:

Group with walking aids will undergo intervention. Baseline and endline measurements.

Treatment:

Combination Product: VOILA

Knee replacement INT

Experimental group

Description:

Group with recent knee replacement surgery will undergo intervention. Baseline and endline measurements.

Treatment:

Combination Product: VOILA

Knee replacement Control

No Intervention group

Description:

Group with recent knee replacement surgery will undergo standard care. Baseline and endline measurements.