The Effects of a Multidomain Lifestyle Intervention on Brain Functioning and Its Relation With Immunometabolic Markers in Ageing: the HELI Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Change in working memory performance
研究概览
简要总结
HELI is a multicenter, randomised controlled trial in two Dutch research centres (Donders Centre for Cognitive Neuroimaging, Nijmegen, and the department of Human Nutrition & Health at Wageningen University) among 104 older adults aged 60-75 years who are at risk for cognitive decline with an intervention duration of 26 weeks (roughly 6 months). Participants are randomized in a 1:1 ratio to a multidomain lifestyle intervention characterized by group-sessions and guidance (high-intensity intervention group) versus online access to general lifestyle-related health information in the form of biweekly leaflets (low-intensity intervention group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants come for baseline outcome measurement visits in Nijmegen and Wageningen prior to randomization. The follow-up measurements are carried out by researchers, investigators and research-assistants who are not guiding the intervention groups, have no contact with included participants after randomization, and are not involved in the randomization process.
Participants are aware of their group allocation, as it is clear to participants multiple groups are formed which differ in the way the intervention material is provided.
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent;
- •Age between 60-75 years (at pre-screening);
- •Fluency in Dutch (speaking, reading and writing);
- •Lives near study centres in Nijmegen and Wageningen (max. 50 kilometers of travelling, to ensure study centre visits are possible without excessive travel burden);
- •Presence of ≥2 self-reported risk factors for cognitive decline (BMI of 30 or higher, physical inactivity according to World Health Organization guidelines, hypertension [not using hypertensive drugs counts as an additional risk factor], hypercholesterolemia, diabetes type-II, non-symptomatic cardiovascular disease).
排除标准
- •Concurrent participation in other intervention trials;
- •Technologically illiterate (complete incompetence in working with computers, apps, online questionnaires, etc.);
- •No internet access from home;
- •Clinical diagnosis of ≥1 of the following: vascular event (CVA), neurological pathology (e.g. mild cognitive impairment, dementia, multiple sclerosis, Parkinson's, epilepsy), current malignant disease(s) (with or without current treatment), current psychiatric disorder(s) (e.g. depression, psychosis, bipolar episodes), symptomatic cardiovascular disease (e.g. stroke, angina pectoris, heart failure, myocardial infarction), revascularisation surgery in the last 12 months at pre-screening, inflammatory bowel disease (characterised with diarrhoea), visual impairment (e.g. blindness), hearing or communicative impairment;
- •Unable to undergo MRI (e.g. metal objects in upper body, past brain surgery, active implants, claustrophobic);
- •Cognitive impairment as determined by the Telephone Interview for Cognitive Status (TICS-M1), performed during pre-screening before inclusion.
研究组 & 干预措施
High-intensity group
The high-intensity group receives a supervised multidomain lifestyle intervention consisting of weekly group meetings. During the weekly group meetings, information and exercises are provided, and participants are able to exchange experiences and advice with other group members.
干预措施: Multidomain lifestyle intervention (Behavioral)
Low-intensity group
The low-intensity group only receives access to general lifestyle-related health information through biweekly leaflets, which are provided through e-mail.
结局指标
主要结局
Change in working memory performance
时间窗: Change between Baseline (T0) and Follow-up after 6 months (T1)
Task accuracy during N-back (2-back) fMRI task
Change in brain activity during working memory
时间窗: Change between Baseline (T0) and Follow-up after 6 months (T1)
Blood-oxygen level dependent activity during N-back (2-back) fMRI task
Change in inflammatory profile in blood plasma: TNF-α
时间窗: Change between Baseline (T0) and Follow-up after 6 months (T1)
Blood plasma inflammatory profile analysis to measure TNF-α level
Change in cerebral perfusion levels
时间窗: Change between Baseline (T0) and Follow-up after 6 months (T1)
Cerebral perfusion measured using arterial spin labelling (ASL)
Change in inflammatory profile in blood plasma: IL-6
时间窗: Change between Baseline (T0) and Follow-up after 6 months (T1)
Blood plasma inflammatory profile analysis to measure IL-6 level
Change in inflammatory profile in blood plasma: hs-CRP
时间窗: Change between Baseline (T0) and Follow-up after 6 months (T1)
Blood plasma inflammatory profile analysis to measure hs-CRP level
Change in microbiota profile
时间窗: Change between Baseline (T0) and Follow-up after 6 months (T1)
16S rRNA based profile of gut microbiota in faeces
次要结局
- Change in Eetscore food questionnaire (questionnaire)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in microbiome-derived bioactive compounds (faeces)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Gut transit time(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in inflammation profile (blood)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Waist circumference(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Intracranial iron deposition (neuroimaging)(Baseline (T0))
- Change in Digit Symbol Substitution Test (DSST) (cognitive assessment)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Sedentary Behaviour Questionnaire (questionnaire)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Body mass index(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Trail Making Test A (TMT-A) Numbers : trial time (cognitive assessment)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Blood pressure(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Abdominal fat distribution (neuroimaging)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Brain myo-inositol levels (neuroimaging)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Trail Making Test B (TMT-B) Numbers and Letters: errors (cognitive assessment)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Hip circumference(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Brain structure volume profile (neuroimaging)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Rey Auditory Verbal Learning Test (RAVLT): learning trials (cognitive assessment)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Pittsburgh Sleep Quality Index (PSQI) (questionnaire)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in SQUASH (questionnaire)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Cognitive Failures Questionnaire (questionnaire)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Memory Self-Efficacy MIA (questionnaire)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Neuropsychological test battery scoring(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Trail Making Test A (TMT-A) Numbers: errors (cognitive assessment)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Trail Making Test B (TMT-B) Numbers and Letters : trial time (cognitive assessment)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Rey Auditory Verbal Learning Test (RAVLT): delayed recall (cognitive assessment)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in individual short-chain fatty acids (SCFAs) profile (faeces)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in brain health profile (blood)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Verbal Fluency Test (VFT) (cognitive assessment)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in white blood cell count (blood)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in total amount of bacteria, fungi and specific bacterial strains (faeces)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Wechsler Adult Intelligence Scale (WAIS) digit span (cognitive assessment)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Five Facet Mindfulness Questionnaire (questionnaire)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in Perceived Stress Scale (questionnaire)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in intestinal inflammation profile (faeces)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in small intestinal bacterial overgrowth (SIBO) (breath)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in metabolic profile (blood)(Change between Baseline (T0) and Follow-up after 6 months (T1))
- Change in intestinal integrity profile (blood)(Change between Baseline (T0) and Follow-up after 6 months (T1))