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Trials / Completed

CompletedNCT04135066

Westlake Nutrition and Brain Health Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
1,425 (actual)
Sponsor
Westlake University · Academic / Other
Sex
All
Age
45 Years
Healthy volunteers
Accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERRefine grain breakfastAfter 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.
OTHERWhole grain breakfastAfter 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.
OTHEROral Glucose Tolerance test (75g 2-hour)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.

Timeline

Start date
2020-11-01
Primary completion
2025-04-28
Completion
2025-05-21
First posted
2019-10-22
Last updated
2025-06-13

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT04135066. Inclusion in this directory is not an endorsement.