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CompletedNCT05777863HELIUpdated Jun 21, 2024

The Effects of a Multidomain Lifestyle Intervention on Brain Functioning and Its Relation With Immunometabolic Markers in Ageing

An interventional study of Multidomain lifestyle intervention in Life Style, Risk Reduction and Cognitive Decline, sponsored by Donders Centre for Cognitive Neuroimaging. Completed at 2 sites in Netherlands. Open to participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-21.

Sponsored by Donders Centre for Cognitive Neuroimaging · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled May 2022, registered Sep 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
60 Years to 75 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Life Style
  • Risk Reduction
  • Cognitive Decline
  • Aging
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 102 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Donders Centre for Cognitive Neuroimaging is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Multidomain lifestyle intervention

  • No intervention
    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.

Interventions

  • BehavioralMultidomain lifestyle intervention

    A multidomain lifestyle intervention including the following lifestyle domains: (1) diet, (2) physical activity, (3) sleep, (4) stress/mindfulness, and (5) cognitive training.

06

What researchers measure

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

Secondary outcomes

  1. Change in Body mass index

    Measured in kg/m\^2

    Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)

  2. Change in Waist circumference

    Measured in cm

    Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)

  3. Change in Hip circumference

    Measured in cm

    Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. Intracranial iron deposition (neuroimaging)

    Local aggregation of iron deposition within the brain, measured by quantitative susceptibility mapping (QSM)

    Time frame: Baseline (T0)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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)

  18. 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)

  19. 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)

  20. 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)

  21. 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)

  22. 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)

  23. 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)

  24. 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)

  25. 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)

  26. 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)

  27. 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)

  28. 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)

  29. 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)

  30. 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)

  31. 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)

  32. 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)

  33. 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)

  34. 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)

  35. 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)

  36. 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)

  37. 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)

Other outcomes

  1. Montreal Cognitive Assessment (MOCA) (cognitive assessment)

    Discrete number; score 0 - 30. Higher score indicates better cognitive performance (≥26 indicates normal cognitive functioning)

    Time frame: Baseline (T0)

  2. Baseline Demographics and medical history (questionnaire)

    Demographic information, medical history and medication use - qualitative assessment

    Time frame: Baseline (T0)

  3. Change in 4DKL (questionnaire)

    (Psychosocial) complaints in daily life; separate scores for distress (\>10 moderate, \>20 severe), depression (\>2 moderate, \>5 severe), anxiety (\>3 moderate, \>9 severe) and somatisation (\>10 moderate, \>20 severe)

    Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)

  4. Change in EQ-5D-5L (questionnaire)

    Quality of life; score 0 - 100. Higher score indicate better quality of life

    Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)

  5. Change in LIBRA (questionnaire)

    Modifiable dementia risk using lifestyle for brain health; score -5.9 - +12.7. Higher score indicates a worse outcome (higher dementia risk)

    Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)

  6. Change in Lubben Social Network Scale (questionnaire)

    Social contact and perceived social support; score 0 - 30. Higher score indicates a better outcome (higher level of perceived social support)

    Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)

  7. Change in SARC-F Sarcopenia questionnaire (questionnaire)

    Sarcopenia; score 0 - 10 (i.e. 0-2 points for each component; 0 = best to 10 = worst)

    Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)

  8. Change in Cognitive Emotions Regulation Questionnaire (questionnaire)

    Cognitive coping strategies. Answers are scored on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). The scoring takes the average of all the scores in each subscale of cognitive reappraisal and expressive suppression

    Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)

  9. Change in Hospital Anxiety and Depression Scale (questionnaire)

    Anxiety and depression; separate scores for anxiety (0 - 21) and depression (0 - 21). For each domain, a score \>8 indicates psychiatric condition of anxiety or depression

    Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)

  10. Change in Starkstein Apathy Scale (questionnaire)

    Screen and measure apathetic symptoms. A higher total score (range 0-42) indicates more severe apathy, with a score greater than 14 or greater is indicative of clinical apathy

    Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)

  11. Change in COVID status (questionnaire)

    Vaccination status, COVID history - qualitative assessment

    Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)

  12. Change in Gastrointestinal symptoms questionnaire (questionnaire)

    Gastrointestinal symptoms, qualitative assessment

    Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)

  13. Change in Bristol stool chart (questionnaire)

    Classification of faeces type, qualitative assessment

    Time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)

07

Study locations

2 sites
  • Donders Centre for Cognitive Neuroimaging
    Nijmegen, Gelderland, Netherlands
  • Wageningen University & Research
    Wageningen, Gelderland, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05777863
Lead sponsor
Donders Centre for Cognitive Neuroimaging
Collaborators
Wageningen University and Research
Responsible party
Sponsor
First posted
Mar 21, 2023
Start date
May 10, 2022
Primary completion
May 23, 2024
Completion
May 23, 2024
Last update
Jun 21, 2024

Study contacts

Esther Aarts, PhD
principal investigator · Donders Centre for Cognitive Neuroimaging

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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