The effects of a multidomain lifestyle intervention on brain functioning and its relation with immunometabolic markers in ageing
- Conditions
- risicofactoren voor cognitief functioneren (cognitieve veroudering)brain healthcognitive ageing10001474
- Registration Number
- NL-OMON54045
- Lead Sponsor
- Radboud Universiteit Nijmegen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 104
- 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: <300 min of
moderate intensity aerobic physical activity, or <150 min of vigorous intensity
aerobic physical activity per week, spread out over several days) (1 point)
3. Hypertension (1 point, 2 points if hypertension is untreated)
4. Hypercholesterolemia (1 point)
5. Diabetes type-II (1 point)
6. Cardiovascular disease (EXCEPT: symptomatic cardiovascular disease such as
stroke, angina pectoris, heart failure, myocardial infarction, OR
revascularisation surgery in the last 12 months at pre-screening) (1 point)
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Our primary study objectives, with the forthcoming primary study outcomes, are:<br /><br><br /><br>Step 1.<br /><br>a) Brain activity during working memory:<br /><br>BOLD activity and task-accuracy during N-back fMRI task.<br /><br><br /><br>b) Cerebral perfusion levels:<br /><br>MRI-ASL levels.<br /><br><br /><br>c) Peripheral immunometabolic markers:<br /><br>Inflammation markers (IL-6, TNF-a, hs-CRP; from blood plasma) & gut microbiome<br /><br>composition (diversity and richness; from faeces).<br /><br><br /><br><br /><br>Step 2.<br /><br>To investigate intervention-induced immunometabolic-brain links by analysing<br /><br>the relations between the sign-effects of step 1 (see a, b, and c). </p><br>
- Secondary Outcome Measures
Name Time Method