Westlake Nutrition and Brain Health Study (WEBRAIN)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aging
• Intervention / Treatment: Other: Refine grain breakfast; Other: Whole grain breakfast

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 Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ju-Sheng Zheng, PhD; Phone Number: 86-0571-86915303; Email: zhengjusheng@westlake.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510275
      • Sun Yat-sen University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310024
      • Westlake University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Refined grain breakfast; white bread (100g) + milk powder (25g)	Other: Refine grain breakfast; After wearing continuous glucose monitoring device (CGM) on baseline, participants will be provided with breakfast A on two consecutive days in a whoe 14-day monitoring period. The appearance of breakfast A is pseudorandom. Breakfast A contains white bread (100g) and milk powder (25g). Since lunch and dinner would serve as wash-out meals, participants will be free to choose food but provide a record of their diets.; Other Names: Breakfast A
Other: Whole grain breakfast; plain oats (70g) + milk powder (25g)	Other: Whole grain breakfast; After wearing CGM on baseline, participants will be provided with breakfast B on two consecutive days in a whoe 14-day monitoring period. The appearance of breakfast B is pseudorandom. Breakfast B contains plain oats (70g) and milk powder (25g). Since lunch and dinner would serve as wash-out meals, participants will be free to choose food but provide a record of their diets.; Other Names: Breakfast B

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive scores	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.	at enrollment
incidence of Alzheimer's disease (AD)	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).	6 and 10 years after enrollment

Collaborators and Investigators

• Sponsor: Westlake University
• Collaborators: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Estimated): April 28, 2025
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: October 13, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Microbiome; Nutrition; Brain structure and function; Continuous blood glucose monitoring
• Other Study ID Numbers: 20190901ZJS0010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No