The PRECISION-T2D Study: Precision Nutrition Study for Type 2 Diabetes

NCT05885828 | Recruiting DMC

• 1 other identifier: 20230306ZJS002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

Food plays a crucial role in determining blood glucose levels, especially in people with type 2 diabetes. Precision nutrition, which involves individually tailored dietary interventions, can be a powerful tool in managing blood glucose levels in people with type 2 diabetes. Previous studies found that changes in gut microbiota resulted from the dietary intervention, such as plant-based diet, might subsequently lead to different glycemic responses, and then different health outcomes. In this study, the investigators will characterize the blood glucose dynamics and gut microbiota of individuals with type 2 diabetes. They aim to assess the influence of plant-based diet on gut microbiota; they will also investigate the influence of gut microbiota on glycemic responses. Additionally, a series of individual N-of-1 trails will be integrated to compare the effects of a white bread breakfast and a whole wheat bread breakfast on glucose metabolism at the individual level.

Conditions

Type 2 Diabetes

Keywords

N-of-1; plant-based diet; precision nutrition; continuous glucose monitoring; type 2 diabetes

Outcome Measures

Primary Outcomes (2)

• Changes in gut microbiome profile

  Shotgun metagenomic sequencing will be performed in stool samples.

  Day 1 and Day 31

• Blood glucose profile

  Real-time blood glucose fluctuations will be recorded using continuous glucose monitoring.

  2 weeks

Secondary Outcomes (8)

• Carotid plaque

  At enrollment

• Carotid intima-media thickness

  At enrollment

• Number of participants with chronic kidney disease

  Up to 10 years

• Cognitive function

  Up to 10 years

• Changes in fasting blood glucose

  Day 1 and Day 31

Study Arms (2)

Plant-based diet

EXPERIMENTAL

Participants in this arm will be recommended to consume more fiber-rich foods, including whole grains, fruits, legumes and vegetables; to moderate their intake of fish, eggs and dairy products; and to avoid other animal products. All participants are instructed not to modify their exercise habits during the intervention period.

Other: White bread; Other: Whole wheat bread; Behavioral: Plant-based diet; Other: Follow-up visit every 1-2 years

Conventional diabetic diet

EXPERIMENTAL

Participants in this arm will be recommended to have a diet following 2023 Chinese Diabetes Society guidelines. All participants are instructed not to modify their exercise habits during the intervention period.

Other: White bread; Other: Whole wheat bread; Other: Conventional diabetic diet; Other: Follow-up visit every 1-2 years

Interventions

White bread OTHER

After wearing CGM on Day 1, participants will be provided with white bread (76-77g) and milk (250mL) for breakfast on Day 3, Day 4, Day 7, Day 8, Day 10, Day 12.

Also known as: Breakfast A

Conventional diabetic diet; Plant-based diet

Whole wheat bread OTHER

After wearing CGM on Day 1, participants will be provided with wheat bread (85-86g) and milk (250mL) for breakfast on Day 2, Day 5, Day 6, Day 9, Day 11, Day 13.

Also known as: Breakfast B

Conventional diabetic diet; Plant-based diet

Plant-based diet BEHAVIORAL

After wearing CGM on Day 1, participants will be asked to follow the plant-based diet in next 30 days.

Plant-based diet

Conventional diabetic diet OTHER

Volunteers will be asked to have a diet following 2023 Chinese Diabetes Society guidelines in next 30 days.

Conventional diabetic diet

Follow-up visit every 1-2 years OTHER

Participants will be visited every 1-2 years. At each visit, face-to-face interviews, specimen collection, anthropometric measurements, ultrasonography evaluation, laboratory tests, and multi-omics data will be conducted.

Conventional diabetic diet; Plant-based diet

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with type 2 diabetes;
• Living in Hangzhou for at least five years;
• Have the willingness or ability to complete the intervention and sample collection

You may not qualify if:

• Mental and physical disability;
• Already is a vegetarian;
• Cancer and serious complications from type 2 diabetes, such as renal failure;
• Using insulin for more than 5 years;
• Unstable medical/medication status;
• Current alcohol or drug abuse;
• Taking antibiotics in the last three months

Sponsors & Collaborators

• Westlake University: lead
• The Third People's Hospital of Hangzhou: collaborator

Study Sites (2)

Westlake University

Hangzhou, Zhejiang, 310030, China

RECRUITING

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, 310058, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Ju-Sheng Zheng, PhD

  Westlake University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ju-Sheng Zheng, PhD

CONTACT

86-0571-88112056; zhengjusheng@westlake.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: June 2, 2023
• Study Start: July 17, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2033
• Last Updated: June 13, 2025

Record last verified: 2025-05

Locations

CN (2)