Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Wageningen University and Research | OTHER |
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-intensity group | Experimental | 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. |
|
| Low-intensity group | No Intervention | The low-intensity group only receives access to general lifestyle-related health information through biweekly leaflets, which are provided through e-mail. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidomain lifestyle intervention | Behavioral | A multidomain lifestyle intervention including the following lifestyle domains: (1) diet, (2) physical activity, (3) sleep, (4) stress/mindfulness, and (5) cognitive training. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in brain activity during working memory | Blood-oxygen level dependent activity during N-back (2-back) fMRI task | 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 | Change between Baseline (T0) and Follow-up after 6 months (T1) |
| Change in cerebral perfusion levels | Cerebral perfusion measured using arterial spin labelling (ASL) | 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 | 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 | 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 | Change between Baseline (T0) and Follow-up after 6 months (T1) |
| Change in microbiota profile | 16S rRNA based profile of gut microbiota in faeces | Change between Baseline (T0) and Follow-up after 6 months (T1) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body mass index | Measured in kg/m^2 | Change between Baseline (T0) and Follow-up after 6 months (T1) |
| Change in Waist circumference | Measured in cm |
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment (MOCA) (cognitive assessment) | Discrete number; score 0 - 30. Higher score indicates better cognitive performance (≥26 indicates normal cognitive functioning) | Baseline (T0) |
| Baseline Demographics and medical history (questionnaire) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Esther Aarts, PhD | Donders Centre for Cognitive Neuroimaging | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Donders Centre for Cognitive Neuroimaging | Nijmegen | Gelderland | Netherlands | |||
| Wageningen University & Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41543363 | Derived | 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. |
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Participants come for baseline outcome measurement visits in Nijmegen and Wageningen prior to randomization. The follow-up measurements are carried out by researchers, investigators and research-assistants who are not guiding the intervention groups, have no contact with included participants after randomization, and are not involved in the randomization process.
Participants are aware of their group allocation, as it is clear to participants multiple groups are formed which differ in the way the intervention material is provided.
| Change between Baseline (T0) and Follow-up after 6 months (T1) |
| Change in Hip circumference | Measured in cm | 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. | 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 | 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 | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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) | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Change between Baseline (T0) and Follow-up after 6 months (T1) |
Demographic information, medical history and medication use - qualitative assessment |
| Baseline (T0) |
| 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) | Change between Baseline (T0) and Follow-up after 6 months (T1) |
| Change in EQ-5D-5L (questionnaire) | Quality of life; score 0 - 100. Higher score indicate better quality of life | Change between Baseline (T0) and Follow-up after 6 months (T1) |
| 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) | Change between Baseline (T0) and Follow-up after 6 months (T1) |
| 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) | Change between Baseline (T0) and Follow-up after 6 months (T1) |
| Change in SARC-F Sarcopenia questionnaire (questionnaire) | Sarcopenia; score 0 - 10 (i.e. 0-2 points for each component; 0 = best to 10 = worst) | Change between Baseline (T0) and Follow-up after 6 months (T1) |
| 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 | Change between Baseline (T0) and Follow-up after 6 months (T1) |
| 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 | Change between Baseline (T0) and Follow-up after 6 months (T1) |
| 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 | Change between Baseline (T0) and Follow-up after 6 months (T1) |
| Change in COVID status (questionnaire) | Vaccination status, COVID history - qualitative assessment | Change between Baseline (T0) and Follow-up after 6 months (T1) |
| Change in Gastrointestinal symptoms questionnaire (questionnaire) | Gastrointestinal symptoms, qualitative assessment | Change between Baseline (T0) and Follow-up after 6 months (T1) |
| Change in Bristol stool chart (questionnaire) | Classification of faeces type, qualitative assessment | Change between Baseline (T0) and Follow-up after 6 months (T1) |
| Wageningen |
| Gelderland |
| Netherlands |
| ID | Term |
|---|---|
| D040242 | Risk Reduction Behavior |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided