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

NCT05777863 | Completed

• 1 other identifier: 3033003.01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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).

Conditions

Life Style; Risk Reduction; Cognitive Decline; Aging

Outcome Measures

Primary Outcomes (7)

• 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)

Secondary Outcomes (37)

• Change in Body mass index

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

• Change in Waist circumference

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

• Change in Hip circumference

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

• Change in Blood pressure

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

• Change in Abdominal fat distribution (neuroimaging)

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

Other Outcomes (13)

• Montreal Cognitive Assessment (MOCA) (cognitive assessment)

  Baseline (T0)

• Baseline Demographics and medical history (questionnaire)

  Baseline (T0)

• Change in 4DKL (questionnaire)

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

Study Arms (2)

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.

Behavioral: Multidomain lifestyle intervention

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.

Interventions

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.

High-intensity group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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);

Sponsors & Collaborators

• Donders Centre for Cognitive Neuroimaging: lead
• Wageningen University and Research: collaborator

Study Sites (2)

Donders Centre for Cognitive Neuroimaging

Nijmegen, Gelderland, Netherlands

Location

Wageningen University & Research

Wageningen, Gelderland, Netherlands

Location

MeSH Terms

Conditions

Risk Reduction Behavior; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Esther Aarts, PhD

  Donders Centre for Cognitive Neuroimaging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: March 21, 2023
• Study Start: May 10, 2022
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

NL (2)