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Life StyleHELINCT05777863

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

A study testing Multidomain lifestyle intervention in people with Life Style and Risk Reduction, run by Donders Centre for Cognitive Neuroimaging at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 60 to 75 years
Conditions the study is for
Life Style, Risk Reduction, Cognitive Decline
What is being tested?
Multidomain lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
2 sitesNetherlands
Study dates
10 May 2022to 23 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Donders Centre for Cognitive Neuroimaging

    Nijmegen, Gelderland

  • Wageningen University & Research

    Wageningen, Gelderland

Other trials in Netherlands

About this study

Official title: The Effects of a Multidomain Lifestyle Intervention on Brain Functioning and Its Relation With Immunometabolic Markers in Ageing: the HELI Study

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).

Being tested
Multidomain lifestyle intervention
Medical subject headings
Risk Reduction Behavior, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multidomain lifestyle interventionBehavioural

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

Study groups in NCT05777863
Study groupRoleWhat they receive
High-intensity groupExperimentalThe 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.
Receives: Behavioral: Multidomain lifestyle intervention
Low-intensity groupNo interventionThe low-intensity group only receives access to general lifestyle-related health information through biweekly leaflets, which are provided through e-mail.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in brain activity during working memory

    Blood-oxygen level dependent activity during N-back (2-back) fMRI task

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

Secondary outcomes (37)

  1. Change in Body mass index

    Measured in kg/m^2

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

  2. Change in Waist circumference

    Measured in cm

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

  3. Change in Hip circumference

    Measured in cm

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2023
  2. Study start10 May 2022
  3. Primary completion23 May 2024
  4. Study completion23 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05777863
Sponsor's protocol ID
3033003.01
Acronym
HELI
Status last verified
Jun 2024
First submitted
27 Sep 2022
Last updated
21 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Beers S, de Groot LCPGM, van Loenen MR, Remie LB, Bromhaar MG, Anesi A, Vrhovsek U, Oosterman JM, Aarts E, van Trijp MPH, Vermeiren Y. Association Between the Dutch Mediterranean-Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay (MIND-NL) Diet Adherence and Systemic Tryptophan Metabolites in Older Adults at Risk of Cognitive Decline: An Exploratory Study. Mol Nutr Food Res. 2026 Jan;70(1):e70377. doi: 10.1002/mnfr.70377.

    PubMed 41543363

  • van Loenen MR, Remie LB, van Trijp MP, Jansen MG, Marques JP, Claassen JA, van de Rest O, Vermeiren Y, Smidt N, Sikkes SA, Deckers K, Zwan MD, van der Flier WM, Kohler S, Steegenga WT, Oosterman JM, Aarts E. The Effects of a Multidomain Lifestyle Intervention on Brain Function and Its Relation With Immunometabolic Markers and Intestinal Health in Older Adults at Risk of Cognitive Decline: Study Design and Baseline Characteristics of the HELI Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 15;14:e69814. doi: 10.2196/69814.

    PubMed 41252227

Questions about this trial

What is this clinical trial studying?

A study testing Multidomain lifestyle intervention in people with Life Style and Risk Reduction, run by Donders Centre for Cognitive Neuroimaging at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in brain activity during working memory (time frame: Change between Baseline (T0) and Follow-up after 6 months (T1)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05777863, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.

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