Westlake Nutrition and Brain Health Study

Aging Clinical Trial

— WEBRAIN  

Official title:

Westlake Nutrition and Brain Health Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04135066
• Other study ID #: 20190901ZJS0010
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: November 2029

Study information

• Verified date: November 2023
• Source: Westlake University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: November 2029
• Est. primary completion date: April 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Sun Yat-sen University	Guangzhou	Guangdong
China	Westlake University	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Westlake University	Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

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