Clinical trial NCT05777863: The Effects of a Multidomain Lifestyle Intervention on Brain Functioning and Its Relation With Immunometabolic Markers in Ageing
Official title: The Effects of a Multidomain Lifestyle Intervention on Brain Functioning and Its Relation With Immunometabolic Markers in Ageing: the HELI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Life Style
Risk Reduction
Cognitive Decline
Aging
Lead sponsor: Donders Centre for Cognitive Neuroimaging
Sponsor class: OTHER
Collaborators: name: Wageningen University and Research
First posted: 2023-03-21
Enrollment: 102
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multidomain lifestyle intervention. Participants are randomized in a 1:1 ratio to a multidomain lifestyle intervention characterized by group-sessions and supervision (high-intensity intervention group) versus access to general lifestyle-related health information in the form of biweekly leaflets which are provided through e-mail (low-intensity intervention group).
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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).

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. 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.

Primary outcomes:
measure: Change in brain activity during working memory
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in working memory performance
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in cerebral perfusion levels
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in inflammatory profile in blood plasma: hs-CRP
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in inflammatory profile in blood plasma: IL-6
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in inflammatory profile in blood plasma: TNF-α
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in microbiota profile
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Secondary outcomes:
measure: Change in Body mass index
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Waist circumference
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Hip circumference
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Blood pressure
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Abdominal fat distribution (neuroimaging)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Brain structure volume profile (neuroimaging)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Brain myo-inositol levels (neuroimaging)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Intracranial iron deposition (neuroimaging)
timeFrame: Baseline (T0)
measure: Change in Neuropsychological test battery scoring
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Trail Making Test A (TMT-A) Numbers : trial time (cognitive assessment)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Trail Making Test A (TMT-A) Numbers: errors (cognitive assessment)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Trail Making Test B (TMT-B) Numbers and Letters : trial time (cognitive assessment)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Trail Making Test B (TMT-B) Numbers and Letters: errors (cognitive assessment)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Verbal Fluency Test (VFT) (cognitive assessment)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Rey Auditory Verbal Learning Test (RAVLT): learning trials (cognitive assessment)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Rey Auditory Verbal Learning Test (RAVLT): delayed recall (cognitive assessment)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Digit Symbol Substitution Test (DSST) (cognitive assessment)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Wechsler Adult Intelligence Scale (WAIS) digit span (cognitive assessment)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Five Facet Mindfulness Questionnaire (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Sedentary Behaviour Questionnaire (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Eetscore food questionnaire (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Perceived Stress Scale (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Pittsburgh Sleep Quality Index (PSQI) (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in SQUASH (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Cognitive Failures Questionnaire (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Memory Self-Efficacy MIA (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in total amount of bacteria, fungi and specific bacterial strains (faeces)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in individual short-chain fatty acids (SCFAs) profile (faeces)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in microbiome-derived bioactive compounds (faeces)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in intestinal inflammation profile (faeces)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Gut transit time
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in metabolic profile (blood)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in inflammation profile (blood)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in intestinal integrity profile (blood)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in brain health profile (blood)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in white blood cell count (blood)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in small intestinal bacterial overgrowth (SIBO) (breath)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Other outcomes:
measure: Montreal Cognitive Assessment (MOCA) (cognitive assessment)
timeFrame: Baseline (T0)
measure: Baseline Demographics and medical history (questionnaire)
timeFrame: Baseline (T0)
measure: Change in 4DKL (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in EQ-5D-5L (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in LIBRA (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Lubben Social Network Scale (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in SARC-F Sarcopenia questionnaire (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Cognitive Emotions Regulation Questionnaire (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Hospital Anxiety and Depression Scale (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Starkstein Apathy Scale (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in COVID status (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Gastrointestinal symptoms questionnaire (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
measure: Change in Bristol stool chart (questionnaire)
timeFrame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Locations:
city: Nijmegen
country: Netherlands
facility: Donders Centre for Cognitive Neuroimaging
state: Gelderland
city: Wageningen
country: Netherlands
facility: Wageningen University & Research
state: Gelderland
Study officials:
affiliation: Donders Centre for Cognitive Neuroimaging
name: Esther Aarts, PhD
role: PRINCIPAL_INVESTIGATOR
References: