Westlake Nutrition and Brain Health Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Westlake Nutrition and Brain Health Study

Conditions
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Aging

Intervention / Treatment
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* Other: Refine grain breakfast
* Other: Whole grain breakfast


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Refined grain breakfast<br>white bread (100g) + milk powder (25g) | Other: Refine grain breakfast<br>* 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.<br>* Other names: Breakfast A;|
| Other: Whole grain breakfast<br>plain oats (70g) + milk powder (25g) | Other: Whole grain breakfast<br>* 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.<br>* Other names: Breakfast B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain images | Brain structure and function was measured by brain magnetic resonance imaging (MRI) | at enrollment | 
| Continuous blood glucose profile over 2 weeks | Glucose levels were measured by continuous glucose monitoring over 2 week | at enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain structure and function, Nutrition, Microbiome, Continuous blood glucose monitoring