The VOILA Intervention Study

NCT05354310 | Unknown DMC

• 1 other identifier: NL76879.058.21
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 3

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.

Conditions

Aging

Keywords

Resistance Training; Nutrition; Protein supplement; Gut microbiome; Immunometabolsim; Mobility

Outcome Measures

Primary Outcomes (6)

• Muscle mass

  appendicular lean mass in kg (DEXA)

  10 weeks

• Muscle function

  5-times repeated chair rise test in seconds

  10 weeks

• Gut health

  bifidobacteria (from stool sample) in log10 cells per gram dried faeces

  10 weeks

• Immuno-metabolic health - GLC

  fasting blood glucose (GLC) in mmol/L

  10 weeks

• Immuno-metabolic health - GlycA

  glycoprotein acetyls (GlycA) in mmol/L

  10 weeks

• Immuno-metabolic health - VLDL

  very low-density lipoprotein (VLDL)-diameter in nm (from Nightingale 1H NMR platform)

  10 weeks

Secondary Outcomes (13)

• Muscle function - SPPB

  10 weeks

• Muscle function - TUG

  10 weeks

• Muscle function - 6MWT

  10 weeks

• Muscle function - 1RM

  10 weeks

• Body composition - Whole body regional lean mass

  10 weeks

Study Arms (5)

Active reference group

NO INTERVENTION

Only baseline measurements will be done.

Metabolically compromised group

EXPERIMENTAL

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

Combination Product: VOILA

Mobility compromised

EXPERIMENTAL

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

Combination Product: VOILA

Knee replacement INT

EXPERIMENTAL

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

Combination Product: VOILA

Knee replacement Control

NO INTERVENTION

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

Interventions

VOILA COMBINATION_PRODUCT

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; Metabolically compromised group; Mobility compromised

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Maastricht University Medical Center: collaborator
• Wageningen University and Research: collaborator
• FrieslandCampina: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (3)

Wageningen University & Research

Wageningen, Gelderland, 6708 WE, Netherlands

RECRUITING

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

Leiden University Medical Center

Leiden, South Holland, 2333 ZC, Netherlands

RECRUITING

Study Officials

• P. Eline Slagboom, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

• Lex Verdijk, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

• Lisette de Groot, PhD

  Wageningen University & Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

P. Eline Slagboom, PhD

CONTACT

0653879941; P.Slagboom@lumc.nl

Jordi Morwani Mangnani, MSc

CONTACT

j.morwani_mangnani@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Molecular Epidemiology

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 29, 2022
• Study Start: February 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Length is not determined.

Locations

NL (3)