Westlake Nutrition and Brain Health Study

Not Applicable

Active, not recruiting

• Conditions: Aging
• Interventions: Other: Whole grain breakfast; Other: Refine grain breakfast

• Registration Number: NCT04135066
• Lead Sponsor: Westlake University

Brief Summary

Westlake Nutrition and Brain Study (WEBRAIN) is a sub-study of the Guangzhou Nutrition and Health Study, a prospective cohort among participants living in Guangzhou city. The aim of the WEBRAIN is to investigate the relationship between diet, gut microbiome and brain health in the elderly individuals via deep phenotyping the participants including continuous blood glucose monitoring for standard test meal, objective physical activity measurement and brain magnetic resonance imaging.

Detailed Description

The gut-brain axis has been considered a possible cause of neurodegenerative diseases via various mechanisms, and diet/nutrition has been linked to both gut and brain health. However, majority of related evidence derived from animal models or human study of small scale.

In the WEBRAIN, we aim to investigate the relationship between diet, gut microbiome and brain structure and function in a large human cohort study via deep phenotyping the participants: 1) objective measurement of physical activity using accelerometers over 2 weeks; 2) continuous blood glucose monitoring over 2 weeks, with two standard test meal during the 2 weeks, and traditional diet assessment with FFQ and 24h recalls; 3) measurement of cognitive function and brain images with the Addenbrooke's Cognitive Examination-Revised (ACE-R) and brain MRI; and 4) measurement of gut microbiome using metagenome and 16S rRNA sequencing techniques.

Study Timeline

• Study First Submitted: 2019-10-13
• Study First Submitted QC: 2019-10-18
• Study First Posted: 2019-10-22
• Study Start: 2020-11-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-07
• Primary Completion: 2025-04-28
• Study Completion: 2029-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Participants within the Guangzhou Nutrition and Health Study, without Alzheimer's disease, lived in Guangzhou, China, and aged 45 years or older;

Exclusion Criteria

Participants with cancer and other serious medical disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Whole grain breakfast	Whole grain breakfast	plain oats (70g) + milk powder (25g)
Refined grain breakfast	Refine grain breakfast	white bread (100g) + milk powder (25g)

Primary Outcome Measures

Name	Time	Method
Continuous blood glucose profile over 2 weeks	at enrollment	Glucose levels were measured by continuous glucose monitoring over 2 week
Brain images	at enrollment	Brain structure and function was measured by brain magnetic resonance imaging (MRI)

Secondary Outcome Measures

Name	Time	Method
Cognitive scores	at enrollment	Cognitive function was measured by the Addenbrooke's Cognitive Examination-Revised (ACE-R). The original 26 components were combined to produce five subscores, 100 in total. The cutoff for dementia is 82-88/100.
incidence of Alzheimer's disease (AD)	6 and 10 years after enrollment	New cases of AD will be diagnosed by neurological clinician according to the Chinese guideline for the diagnosis and treatment of Alzheimer's disease dementia(2020).

Trial Locations

Locations (2)

Westlake University; 🇨🇳 Hangzhou, Zhejiang, China

Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China