An interventional study of Refine grain breakfast and Whole grain breakfast in Aging, sponsored by Westlake University. Completed at 1 site in China. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Westlake University · Not applicable, Interventional, and Other
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.
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.
Westlake University is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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.
Other: Refine grain breakfast · Other: Whole grain breakfast · Other: Oral Glucose Tolerance test (75g 2-hour)
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.
Other: Refine grain breakfast · Other: Whole grain breakfast · Other: Oral Glucose Tolerance test (75g 2-hour)
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.
Other: Refine grain breakfast · Other: Whole grain breakfast · Other: Oral Glucose Tolerance test (75g 2-hour)
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.
Also known as: Breakfast A
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.
Also known as: Breakfast B
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.
Continuous blood glucose profile over 2 weeks
Glucose levels were measured by a continuous glucose monitor over 2 weeks.
Time frame: at enrollment
Brain images
Brain structure and function were measured by brain magnetic resonance imaging (MRI).
Time frame: at enrollment
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.
Time frame: 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).
Time frame: 6 and 10 years after enrollment
Structure of gut microbiome profile
Gut microbiome profile for each participant is measured by metagenome and ITS2 sequencing.
Time frame: At enrollment
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Westlake University