Clinical trial NCT05354310: The VOILA Intervention Study
Official title: Vitality Oriented Innovation for the Lifecourse of the Ageing Society Intervention Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Keywords: Resistance Training
Nutrition
Protein supplement
Gut microbiome
Immunometabolsim
Mobility
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
name: Wageningen University and Research
name: FrieslandCampina
name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2022-04-29
Enrollment: 220
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Muscle mass
timeFrame: 10 weeks
measure: Muscle function
timeFrame: 10 weeks
measure: Gut health
timeFrame: 10 weeks
measure: Immuno-metabolic health - GLC
timeFrame: 10 weeks
measure: Immuno-metabolic health - GlycA
timeFrame: 10 weeks
measure: Immuno-metabolic health - VLDL
timeFrame: 10 weeks
Secondary outcomes:
measure: Muscle function - SPPB
timeFrame: 10 weeks
measure: Muscle function - TUG
timeFrame: 10 weeks
measure: Muscle function - 6MWT
timeFrame: 10 weeks
measure: Muscle function - 1RM
timeFrame: 10 weeks
measure: Body composition - Whole body regional lean mass
timeFrame: 10 weeks
measure: Body composition - Whole body regional fat mass
timeFrame: 10 weeks
measure: Body composition - Regional lean mass
timeFrame: 10 weeks
measure: Body composition - Regional fat mass
timeFrame: 10 weeks
measure: Immuno-metabolic health - Hba1c
timeFrame: 10 weeks
measure: Immuno-metabolic health - Insulin
timeFrame: 10 weeks
measure: Immuno-metabolic health - Blood pressure
timeFrame: 10 weeks
measure: Knee replacement group additional outcomes - CT
timeFrame: 10 weeks
measure: Knee replacement group additional outcomes - WOMAC
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University & Research
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: South Holland
Study officials:
affiliation: Leiden University Medical Center
name: P. Eline Slagboom, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Lex Verdijk, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wageningen University & Research
name: Lisette de Groot, PhD
role: PRINCIPAL_INVESTIGATOR
References: