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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
102
A multidomain lifestyle intervention including the following lifestyle domains: (1) diet, (2) physical activity, (3) sleep, (4) stress/mindfulness, and (5) cognitive training.
Donders Centre for Cognitive Neuroimaging
Nijmegen, Gelderland, Netherlands
Wageningen University & Research
Wageningen, Gelderland, Netherlands
Change in brain activity during working memory
Blood-oxygen level dependent activity during N-back (2-back) fMRI task
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in working memory performance
Task accuracy during N-back (2-back) fMRI task
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in cerebral perfusion levels
Cerebral perfusion measured using arterial spin labelling (ASL)
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in inflammatory profile in blood plasma: hs-CRP
Blood plasma inflammatory profile analysis to measure hs-CRP level
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in inflammatory profile in blood plasma: IL-6
Blood plasma inflammatory profile analysis to measure IL-6 level
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in inflammatory profile in blood plasma: TNF-α
Blood plasma inflammatory profile analysis to measure TNF-α level
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in microbiota profile
16S rRNA based profile of gut microbiota in faeces
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Body mass index
Measured in kg/m\^2
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Waist circumference
Measured in cm
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Hip circumference
Measured in cm
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Blood pressure
Measured by blood pressure monitor. Scores range from approximately (for diastolic) 60-120 and (for systolic) 100-180 mmHg, with higher scores indicating higher blood pressure.
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Abdominal fat distribution (neuroimaging)
Visceral adipose tissue(VAT)/subcutaneous adipose tissue (SAT) ratio measured by abdominal T1-weighted MRI scan
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Brain structure volume profile (neuroimaging)
Brain structure volumes (grey matter, white matter, brain vesicles), measured by MP2RAGE structural sequence
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Brain myo-inositol levels (neuroimaging)
Brain myo-inositol levels reflecting local neuroinflammation in dorsolateral prefrontal cortex and hippocampus, measured by magnetic resonance spectroscopy (MRS)
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Intracranial iron deposition (neuroimaging)
Local aggregation of iron deposition within the brain, measured by quantitative susceptibility mapping (QSM)
Time frame: Baseline (T0)
Change in Neuropsychological test battery scoring
Z-scoring of cognitive assessments targeting cognitive domains predominantly affected by cognitive ageing: executive function (incl. working memory), episodic memory and processing speed
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Trail Making Test A (TMT-A) Numbers : trial time (cognitive assessment)
Discrete number; score 0 - no maximum (seconds to assessment completion). Lower score indicates a better outcome
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Trail Making Test A (TMT-A) Numbers: errors (cognitive assessment)
Discrete number; score 0 - no maximum (amount of errors). Lower score indicates a better outcome
Time frame: 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)
Discrete number; score 0 - no maximum (seconds to assessment completion). Lower score indicates a better outcome
Time frame: 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)
Discrete number; score 0 - no maximum (amount of errors). Lower score indicates a better outcome
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Verbal Fluency Test (VFT) (cognitive assessment)
Word count in one minute; score 0 - no maximum. Higher score indicates a better outcome
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Rey Auditory Verbal Learning Test (RAVLT): learning trials (cognitive assessment)
Discrete number; score 0 - 15 (amount of words remembered during learning trial 1 to 5). Higher score indicates a better score
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Rey Auditory Verbal Learning Test (RAVLT): delayed recall (cognitive assessment)
Discrete number; score 0 - 15 (amount of words remembered during delayed recall). Higher score indicates a better score
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Digit Symbol Substitution Test (DSST) (cognitive assessment)
Discrete number; score 0 - 90 (amount of symbols correctly substituted). Higher score indicates better outcome
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Wechsler Adult Intelligence Scale (WAIS) digit span (cognitive assessment)
Discrete number; score 0 - 90 (amount of digit spans correctly repeated). Higher score indicates better outcome
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Five Facet Mindfulness Questionnaire (questionnaire)
Self-assessment of mindfulness; score 24 - 120. Higher score indicate more mindfulness
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Sedentary Behaviour Questionnaire (questionnaire)
Average hours and minutes of sedentary behavior a day; score 0 - 24 hours. Higher score (more hours) indicates more sedentary behavior
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Eetscore food questionnaire (questionnaire)
Dutch Healthy Diet Index 2015; score 0 - 160. Higher score indicates a better outcome
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Perceived Stress Scale (questionnaire)
Stress perception; score 0 - 40. Higher score indicate more perceived stress
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Pittsburgh Sleep Quality Index (PSQI) (questionnaire)
Sleep quality; score 0 - 21. Higher score (referred to as global or total score) indicates worse sleep quality
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in SQUASH (questionnaire)
Physical activity. METs derived from the Ainsworth's compendium of physical activity will be used to classify physical activity intensity (\<1.5METs- sedentary, 1.6-2.9 METs- light, 3.0-5.9METs- moderate, \>6.0- vigorous physical activity)
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Cognitive Failures Questionnaire (questionnaire)
Subjective cognitive functioning; score 0 - 100. A higher score indicates more subjective cognitive failure
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Memory Self-Efficacy MIA (questionnaire)
Self-evaluation and confidence of memory. Sum of Part 1 + Part 2A and B. Part 1: Strategy (scores 10 - 50, higher scores indicate more use of strategies), Part 2A: Subjective memory functioning (score 23 - 115, higher score indicates better memory self-efficacy) and Part 2B: Locus (score 7 - 35, higher scores indicate better perceived personal control over remembering abilities)
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in total amount of bacteria, fungi and specific bacterial strains (faeces)
Total amount of bacteria, fungi and specific bacterial strains are quantified using digital droplet PCR in faecal samples
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in individual short-chain fatty acids (SCFAs) profile (faeces)
GC-MS and LC-MS measurements to assess profile of individual SCFAs in faecal samples (acetic acid, formic acid, propionic acid, isobutyric acid, butyric acid, isovaleric acid, valeric acid, 4-methyl valeric acid, hexanoic acid, heptanoic acid)
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in microbiome-derived bioactive compounds (faeces)
Amount of microbiome-derived bioactive compounds is measured by untargeted LC-MS microbiota-derived metabolite analysis in faecal samples
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in intestinal inflammation profile (faeces)
Assay-based profile of intestinal inflammation measured in faecal samples
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in Gut transit time
Gut transit time measured by blue muffin consumption and appearance in faeces
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in metabolic profile (blood)
Assay-based profile of (energy) metabolism measured in plasma samples
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in inflammation profile (blood)
Assay-based profile of systemic inflammation measured in plasma samples
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in intestinal integrity profile (blood)
Assay-based profile of intestinal integrity measured in plasma samples
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in brain health profile (blood)
Assay-based profile of brain health measured in plasma samples
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in white blood cell count (blood)
White blood cell count measured via finger prick analysis
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
Change in small intestinal bacterial overgrowth (SIBO) (breath)
Measurement of total exhaled hydrogen gas after glucose consumption in breath samples
Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)
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