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NCT Number: NCT04135066

Westlake Nutrition and Brain Health Study

The Westlake Nutrition and Brain Study (WEBRAIN), a sub-study of the Guangzhou Nutrition and Health Study, is a prospective cohort study of residents in Guangzhou city. WEBRAIN aims to explore the links between diet, gut microbiome, and brain health in elderly individuals through comprehensive phenotyping, including continuous blood glucose monitoring for standardized test meals, objective physical activity measurement, and brain magnetic resonance imaging.

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Key information

Conditions

Aging

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-sen University

Guangzhou, Guangdong, 510275, China

About this study

The gut-brain axis is implicated in neurodegenerative diseases through various mechanisms, with diet and nutrition linked to both gut and brain health. However, most evidence comes from animal models or small-scale human studies.

The Westlake Nutrition and Brain Study (WEBRAIN) aims to investigate the relationships among diet, gut microbiome, and brain structure and function in a large human cohort through comprehensive phenotyping: 1) objective physical activity measurement using accelerometers over two weeks; 2) continuous blood glucose monitoring for two weeks, including two standardized test meals, alongside traditional dietary assessment via Food Frequency Questionnaires (FFQ) and 24-hour recalls; 3) assessment of cognitive function and brain imaging using the Addenbrooke's Cognitive Examination-Revised (ACE-R) and brain MRI; and 4) gut microbiome profiling analysis using sequencing techniques.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants from the Guangzhou Nutrition and Health Study, lived in Guangzhou, China, and aged 45 years or older;

Exclusion criteria

Metal implants and other contraindications for magnetic resonance imaging scanning

Treatment and study plan

Refine grain breakfast

Other

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

Whole grain breakfast

Other

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

Oral Glucose Tolerance test (75g 2-hour)

Other

75 g pure glucose with 300 mL water per time per person is applied. In the following 3 hours, participants are advised to rest in a seated position, avoiding unnecessary walking or exercise. Energy-giving food items were still prohibited within this interval.

Primary outcomes

  1. Continuous blood glucose profile over 2 weeks

    Time frame: at enrollment

    Glucose levels were measured by a continuous glucose monitor over 2 weeks.

  2. Brain images

    Time frame: at enrollment

    Brain structure and function were measured by brain magnetic resonance imaging (MRI).

Secondary outcomes

  1. Cognitive scores

    Time frame: 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.

  2. Incidence of Alzheimer's disease (AD)

    Time frame: 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).

  3. Structure of gut microbiome profile

    Time frame: At enrollment

    Gut microbiome profile for each participant is measured by metagenome and ITS2 sequencing.

Sponsors and collaborators

Lead sponsor

Westlake University

Other

Collaborators

  • Sun Yat-sen University

Registry information

Acronym: WEBRAIN

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2019
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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