Westlake Nutrition and Brain Health Study

NCT04135066 | Completed DMC

• 1 other identifier: 20190901ZJS0010
• Study Type: interventional
• Target: 1,425
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging

Keywords

Brain structure and function; Nutrition; Microbiome; Continuous blood glucose monitoring

Outcome Measures

Primary Outcomes (2)

• Continuous blood glucose profile over 2 weeks

  Glucose levels were measured by a continuous glucose monitor over 2 weeks.

  at enrollment

• Brain images

  Brain structure and function were measured by brain magnetic resonance imaging (MRI).

  at enrollment

Secondary Outcomes (3)

• Cognitive scores

  at enrollment

• Incidence of Alzheimer's disease (AD)

  6 and 10 years after enrollment

• Structure of gut microbiome profile

  At enrollment

Study Arms (3)

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.

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.

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.

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

Interventions

Refine grain breakfast OTHER

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

Group A (RG-WG-OGTT); Group B (WG-OGTT-RG); Group C (OGTT-RG-WG)

Whole grain breakfast OTHER

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

Group A (RG-WG-OGTT); Group B (WG-OGTT-RG); Group C (OGTT-RG-WG)

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.

Group A (RG-WG-OGTT); Group B (WG-OGTT-RG); Group C (OGTT-RG-WG)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants from the Guangzhou Nutrition and Health Study, lived in Guangzhou, China, and aged 45 years or older;

You may not qualify if:

• Metal implants and other contraindications for magnetic resonance imaging scanning

Sponsors & Collaborators

• Westlake University: lead
• Sun Yat-sen University: collaborator

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510275, China

Location

MeSH Terms

Interventions

Glucose Tolerance Test

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: October 22, 2019
• Study Start: November 1, 2020
• Primary Completion: April 28, 2025
• Study Completion: May 21, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)