Westlake Nutrition and Brain Health Study (WEBRAIN)

Westlake University

Status: Completed

Conditions: Aging

Treatments: Other: Whole grain breakfast; Other: Oral Glucose Tolerance test (75g 2-hour); Other: Refine grain breakfast

Study type: Interventional

Funder types: Other

Identifiers

NCT04135066

20190901ZJS0010

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,425 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,425 participants in 3 patient groups

Group A (RG-WG-OGTT)

Other group

Description:

Starting on Day 1 with a continuous glucose monitoring (CGM) sensor, refined grain breakfasts (RG) are provided on Days 3 and 4, whole grain breakfasts (WG) are provided on Days 6 and 7, and an oral glucose tolerance test (OGTT) is conducted on Day 9. On other days during CGM activation, breakfast is unrestricted.

Treatment:

Other: Refine grain breakfast

Other: Oral Glucose Tolerance test (75g 2-hour)

Other: Whole grain breakfast

Group B (WG-OGTT-RG)

Other group

Description:

Starting on Day 1 with a continuous glucose monitoring (CGM) sensor, whole grain breakfasts (WG) are provided on Days 3 and 4, an oral glucose tolerance test (OGTT) is conducted on Day 6, and refined grain breakfasts (RG) are provided on Days 8 and 9. On other days during CGM activation, breakfast is unrestricted.

Treatment:

Other: Refine grain breakfast

Other: Oral Glucose Tolerance test (75g 2-hour)

Other: Whole grain breakfast

Group C (OGTT-RG-WG)

Other group

Description:

Starting on Day 1 with a continuous glucose monitoring (CGM) sensor, an oral glucose tolerance test (OGTT) is conducted on Day 3, refined grain breakfasts (RG) are provided on Days 5 and 6, and whole grain breakfasts (WG) are provided on Days 8 and 9. On other days during CGM activation, breakfast is unrestricted.

Treatment:

Other: Refine grain breakfast

Other: Oral Glucose Tolerance test (75g 2-hour)

Other: Whole grain breakfast