Vitality Oriented Innovation for the Lifecourse of the Ageing Society Intervention Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 220
- 试验地点
- 6
- 主要终点
- Immuno-metabolic health - GLC
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Immuno-metabolic health - GLC
时间窗: 10 weeks
fasting blood glucose (GLC) in mmol/L
Gut health
时间窗: 10 weeks
bifidobacteria (from stool sample) in log10 cells per gram dried faeces
Muscle mass
时间窗: 10 weeks
appendicular lean mass in kg (DEXA)
Muscle function
时间窗: 10 weeks
5-times repeated chair rise test in seconds
Immuno-metabolic health - VLDL
时间窗: 10 weeks
very low-density lipoprotein (VLDL)-diameter in nm (from Nightingale 1H NMR platform)
Immuno-metabolic health - GlycA
时间窗: 10 weeks
glycoprotein acetyls (GlycA) in mmol/L
次要结局
- Immuno-metabolic health - Hba1c(10 weeks)
- Immuno-metabolic health - Blood pressure(10 weeks)
- Muscle function - 6MWT(10 weeks)
- Body composition - Whole body regional lean mass(10 weeks)
- Knee replacement group additional outcomes - WOMAC(10 weeks)
- Immuno-metabolic health - Insulin(10 weeks)
- Muscle function - 1RM(10 weeks)
- Knee replacement group additional outcomes - CT(10 weeks)
- Muscle function - SPPB(10 weeks)
- Muscle function - TUG(10 weeks)
- Body composition - Regional fat mass(10 weeks)
- Body composition - Whole body regional fat mass(10 weeks)
- Body composition - Regional lean mass(10 weeks)
研究者
P.Eline Slagboom
Professor of Molecular Epidemiology
Leiden University Medical Center