Multicultural Healthy Diet to Reduce Cognitive Decline & Alzheimer's Disease Risk: Study protocol for a pilot randomized controlled trial.
Alzheimer's disease
Ambulatory cognitive monitoring
Cognitive function
Diet assessment
Food record
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
01 2023
01 2023
Historique:
received:
22
07
2022
revised:
13
10
2022
accepted:
10
11
2022
pmc-release:
01
01
2024
pubmed:
18
11
2022
medline:
17
1
2023
entrez:
17
11
2022
Statut:
ppublish
Résumé
Emerging evidence indicates that healthy dietary patterns are associated with higher cognitive status; however, few clinical trials have explored this association in diverse middle-aged adults before the onset of cognitive decline. We use novel ambulatory methods to assess cognition in natural settings in tandem with diet recording. We investigate whether the Multicultural Healthy Diet Study to Reduce Cognitive Decline & Alzheimer's Disease Risk, a pilot randomized controlled trial of an anti-inflammatory dietary pattern compared to usual diet, can mitigate cognitive decline and Alzheimer's Disease risk in a diverse population of 40-65 year old adults in Bronx, New York. Primary cognitive outcomes assessed at nine months are collected in an ecological momentary assessment "measurement burst" design, over the course of participants' daily lives. These ultra-brief, ambulatory cognitive assessments examine processing speed, visuospatial working memory, short-term associative memory binding, long-term associative memory, and working memory capacity. Key secondary outcomes relate to comparing dietary intake between study arms with respect to cognitive outcomes. We assess diet with food records using the National Cancer Institute's Automated Self-Administered 24-h record and serum biomarkers. We further investigate the association of self-reported diet and dietary biomarkers with inflammatory-based biomarkers. This randomized controlled trial of diet and cognition for the first time combines novel measures of ambulatory cognitive assessment with web-based assessment of dietary intake recording. This new approach enabled the study to continue in the midst of the COVID-19 pandemic in remote format.
Sections du résumé
BACKGROUND
Emerging evidence indicates that healthy dietary patterns are associated with higher cognitive status; however, few clinical trials have explored this association in diverse middle-aged adults before the onset of cognitive decline. We use novel ambulatory methods to assess cognition in natural settings in tandem with diet recording.
AIMS
We investigate whether the Multicultural Healthy Diet Study to Reduce Cognitive Decline & Alzheimer's Disease Risk, a pilot randomized controlled trial of an anti-inflammatory dietary pattern compared to usual diet, can mitigate cognitive decline and Alzheimer's Disease risk in a diverse population of 40-65 year old adults in Bronx, New York.
METHODS
Primary cognitive outcomes assessed at nine months are collected in an ecological momentary assessment "measurement burst" design, over the course of participants' daily lives. These ultra-brief, ambulatory cognitive assessments examine processing speed, visuospatial working memory, short-term associative memory binding, long-term associative memory, and working memory capacity. Key secondary outcomes relate to comparing dietary intake between study arms with respect to cognitive outcomes. We assess diet with food records using the National Cancer Institute's Automated Self-Administered 24-h record and serum biomarkers. We further investigate the association of self-reported diet and dietary biomarkers with inflammatory-based biomarkers.
CONCLUSION
This randomized controlled trial of diet and cognition for the first time combines novel measures of ambulatory cognitive assessment with web-based assessment of dietary intake recording. This new approach enabled the study to continue in the midst of the COVID-19 pandemic in remote format.
Identifiants
pubmed: 36396064
pii: S1551-7144(22)00332-9
doi: 10.1016/j.cct.2022.107006
pmc: PMC9839583
mid: NIHMS1852544
pii:
doi:
Substances chimiques
Biomarkers
0
Banques de données
ClinicalTrials.gov
['NCT03240406']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
107006Subventions
Organisme : NIA NIH HHS
ID : K99 AG056670
Pays : United States
Organisme : NIA NIH HHS
ID : R01 AG055527
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002556
Pays : United States
Informations de copyright
Copyright © 2022 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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