The VOILA Intervention Study

Aging Clinical Trial

— VOILA  

Official title:

Vitality Oriented Innovation for the Lifecourse of the Ageing Society Intervention Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05354310
• Other study ID #: NL76879.058.21
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: April 2022
• Source: Leiden University Medical Center
• Contact: P. Eline Slagboom, PhD
• Phone: 0653879941
• Email: P.Slagboom[@]lumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: July 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Combination Product:
• VOILA
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.

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	South Holland
Netherlands	Maastricht University Medical Center	Maastricht	Limburg
Netherlands	Wageningen University & Research	Wageningen	Gelderland

Sponsors (5)

Lead Sponsor	Collaborator
Leiden University Medical Center	FrieslandCampina, Maastricht University Medical Center, Wageningen University and Research, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle mass	appendicular lean mass in kg (DEXA)	10 weeks
Primary	Muscle function	5-times repeated chair rise test in seconds	10 weeks
Primary	Gut health	bifidobacteria (from stool sample) in log10 cells per gram dried faeces	10 weeks
Primary	Immuno-metabolic health - GLC	fasting blood glucose (GLC) in mmol/L	10 weeks
Primary	Immuno-metabolic health - GlycA	glycoprotein acetyls (GlycA) in mmol/L	10 weeks
Primary	Immuno-metabolic health - VLDL	very low-density lipoprotein (VLDL)-diameter in nm (from Nightingale 1H NMR platform)	10 weeks
Secondary	Muscle function - SPPB	Short Physical Performance Battery (SPPB)	10 weeks
Secondary	Muscle function - TUG	Timed Up and Go test (TUG)	10 weeks
Secondary	Muscle function - 6MWT	6-minute walking test (6MWT)	10 weeks
Secondary	Muscle function - 1RM	1 repetition maximum test (1RM) as measured on exercise machines	10 weeks
Secondary	Body composition - Whole body regional lean mass	DEXA whole body lean mass in kg	10 weeks
Secondary	Body composition - Whole body regional fat mass	DEXA whole body fat mass in kg	10 weeks
Secondary	Body composition - Regional lean mass	DEXA regional lean mass in kg	10 weeks
Secondary	Body composition - Regional fat mass	DEXA regional fat mass in kg	10 weeks
Secondary	Immuno-metabolic health - Hba1c	haemoglobin A1c (Hba1c)	10 weeks
Secondary	Immuno-metabolic health - Insulin	Insulin in mol/L	10 weeks
Secondary	Immuno-metabolic health - Blood pressure	Blood pressure in mmHg	10 weeks
Secondary	Knee replacement group additional outcomes - CT	Single-slice CT-scans midway the upper legs	10 weeks
Secondary	Knee replacement group additional outcomes - WOMAC	Western Ontario and McMaster Universities Arthritis Index (WOMAC).	10 weeks