risicofactoren voor cognitief functioneren (cognitieve veroudering) brain health cognitive ageing
Conditions
Interventions
The HELI multidomain lifestyle intervention contains five domains, namely (1)
diet, (2) physical activity, (3) sleep, (4) stress/mindfulness, (5) cognitive
training. Every domain will be presented i
Sponsors
Radboud Universiteit Nijmegen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age between 60-75 years (at pre-screening) - Fluency in Dutch (speaking, reading and writing) - Lives near study centres in Nijmegen and Wageningen (maximum of 50km of traveling to either Nijmegen or Wageningen) - Score >=2 points on the 6 modifiable cardiovascular risk factors listed below: 1. BMI >=25 (1 point) 2. Physical inactivity (below the 2020 WHO guidelines, meaning:
Exclusion criteria
Exclusion criteria: - 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. MCI, dementia, MS, Parkinson's, epilepsy); > Current malignant disease(s), with or without 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. - Answering "Yes" on >=1 of the Donders Institute MRI safety screening protocol questions (see 8 questions below): 1. Are there metal objects located in your upper body? Exception: tooth-fillings and/or dental crowns. 2. Are there metal splinters in your body, in particular within the eyes? For example: through labour work in the metal industry. 3. Are there jewellery items or piercings that you are unable to take off? 4. Have you had a brain surgery in the past? 5. Are there active implants present? For example: pacemaker, neurostimulator, insulinpump, hearing aid (that is unable to be removed). 6. Are there any medical plasters or patches that you can*t or may not take off? For example: nicotine patch. 7. Do you suffer from epilepsy? 8. Do you suffer from claustrophobia? - Cognitive impairment as determined by Telephone Interview for Cognitive Status (TICS-M1), performed during pre-screening before inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our primary study objectives, with the forthcoming primary study outcomes, are: Step 1. a) Brain activity during working memory: BOLD activity and task-accuracy during N-back fMRI task. b) Cerebral perfusion levels: MRI-ASL levels. c) Peripheral immunometabolic markers: Inflammation markers (IL-6, TNF-a, hs-CRP; from blood plasma) & gut microbiome composition (diversity and richness; from faeces). Step 2. To investigate intervention-induced immunometabolic-brain links by analysing the relations between the sign-effects of step 1 (see a, b, and c). | — |
Secondary
| Measure | Time frame |
|---|---|
| Our secondary study objectives, with the forthcoming secondary study outcomes, are: a) To identify baseline predictors for cognitive ageing and intervention efficacy: Structural MRI (e.g. grey/white matter volume, ventricular enlargement, abdominal adipose T1 assessment, etc.), neurochemical MR assessments (MRS; myo-inositol, QSM; iron accumulation), and participant demographics at baseline (e.g. age, sex, education level, etc.). b) To investigate the effect of a 26-week multidomain lifestyle intervention on neuropsychological test battery scoring (cognitive functioning): Z-scoring on cognitive domains predominantly affected by cognitive ageing: executive function, working memory and processing speed. c) To investigate which specific lifestyle domains bring about effects on specific measures: Relations between improvement in domain-related questionnaire scores and primary outcome measures. d) To investigate the effect of a 26-week multidomain lifestyle intervention on a broad array of other immunometabolic brain markers relevant for cognitive ageing: Fecal analysis (microbiota quantification of composition; e.g. functional microbiota analysis, analysis for metabolites), plasma analysis (e.g. markers of intestinal integrity, further inflammatory condition assessment, nutritional status, (early) Alzheimer markers, microbiota-derived bioactive compounds), urine analysis (microbiota-derived bioactive compounds), and breath analysis (SIBO; small intestinal bacterial overgrowth). e) To perform a manipulation check to test whether our multidomain lifestyle intervention-induced changes in brain functioning and perfusion in the hippocampus and dl-PFC (regions of interest) predict improved cognitive performance: Relations between changes in the hippocampus and dl-PFC (BOLD-responses and perfusion) and changes in the working memory (fMRI task) and cognitive domain performance score (neuropsychological tests) following the intervention. | — |
Countries
Netherlands
Outcome results
None listed