AgingWEBRAINNCT04135066
Westlake Nutrition and Brain Health Study
A study testing Refine grain breakfast, Whole grain breakfast and Oral Glucose Tolerance test (75g 2-hour) in people with Aging, run by Westlake University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Refine grain breakfast, Whole grain breakfast and Oral Glucose Tolerance test (75g 2-hour)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,425 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 21 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants from the Guangzhou Nutrition and Health Study, lived in Guangzhou, China, and aged 45 years or older;
Who cannot join
- Metal implants and other contraindications for magnetic resonance imaging scanning
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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
- Aging
- Being tested
- Refine grain breakfast, Whole grain breakfast, Oral Glucose Tolerance test (75g 2-hour)
- Keywords
- Brain structure and function, Nutrition, Microbiome, Continuous blood glucose monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refine grain breakfastOther
Also called Breakfast A
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.
Whole grain breakfastOther
Also called Breakfast B
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (RG-WG-OGTT) | Other | 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. Receives: Other: Refine grain breakfast; Other: Whole grain breakfast; Other: Oral Glucose Tolerance test (75g 2-hour) |
| Group B (WG-OGTT-RG) | Other | 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. Receives: Other: Refine grain breakfast; Other: Whole grain breakfast; Other: Oral Glucose Tolerance test (75g 2-hour) |
| Group C (OGTT-RG-WG) | Other | 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. Receives: Other: Refine grain breakfast; Other: Whole grain breakfast; Other: Oral Glucose Tolerance test (75g 2-hour) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous blood glucose profile over 2 weeks
Glucose levels were measured by a continuous glucose monitor over 2 weeks.
Measured: at enrollment
Brain images
Brain structure and function were measured by brain magnetic resonance imaging (MRI).
Measured: at enrollment
Secondary outcomes (3)
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.
Measured: 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).
Measured: 6 and 10 years after enrollment
Structure of gut microbiome profile
Gut microbiome profile for each participant is measured by metagenome and ITS2 sequencing.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Nov 2020
- Primary completion28 Apr 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westlake University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135066
- Sponsor's protocol ID
- 20190901ZJS0010
- Acronym
- WEBRAIN
- Status last verified
- May 2025
- First submitted
- 13 Oct 2019
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Westlake Nutrition and Brain Health Study
- ClinicalTrials.gov ID
- NCT04135066
- Acronym / sponsor ID
- WEBRAIN / 20190901ZJS0010
- Conditions
- Aging
- Keywords
- Brain structure and function, Nutrition, Microbiome, Continuous blood glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,425 participants (actual)
- Lead sponsor
- Westlake UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-sen University
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (RG-WG-OGTT) | Other | 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, 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. |
| Group B (WG-OGTT-RG) | Other | 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. |
| Group C (OGTT-RG-WG) | Other | 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants from the Guangzhou Nutrition and Health Study, lived in Guangzhou, China, and aged 45 years or older;
Key exclusion criteria (1 listed)
- Metal implants and other contraindications for magnetic resonance imaging scanning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Refine grain breakfastAlso: Breakfast AAfter 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 | Group A (RG-WG-OGTT), Group B (WG-OGTT-RG), Group C (OGTT-RG-WG) |
| Whole grain breakfastAlso: Breakfast BAfter 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 | Group A (RG-WG-OGTT), Group B (WG-OGTT-RG), Group C (OGTT-RG-WG) |
| Oral 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. | Other | Group A (RG-WG-OGTT), Group B (WG-OGTT-RG), Group C (OGTT-RG-WG) |
Primary outcome
Continuous blood glucose profile over 2 weeks
Time frame: at enrollment
Glucose levels were measured by a continuous glucose monitor over 2 weeks.
Brain images
Time frame: at enrollment
Brain structure and function were measured by brain magnetic resonance imaging (MRI).
3 secondary outcomes
Cognitive scores
Time frame: at enrollment
Incidence of Alzheimer's disease (AD)
Time frame: 6 and 10 years after enrollment
Structure of gut microbiome profile
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Refine grain breakfast, Whole grain breakfast and Oral Glucose Tolerance test (75g 2-hour) in people with Aging, run by Westlake University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous blood glucose profile over 2 weeks (time frame: at enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.