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

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

Interventions

OTHER

White bread

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.

OTHER

Whole wheat bread

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.

BEHAVIORAL

Plant-based diet

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

OTHER

Conventional diabetic diet

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

OTHER

Follow-up visit every 1-2 years

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.

Sponsors & Collaborators

• The Third People's Hospital of Hangzhou

  collaborator OTHER

• Westlake University

  lead OTHER

Principal Investigators

• Ju-Sheng Zheng, PhD · Westlake University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-17

Primary Completion

2025-12-31

Completion

2033-12-01

Countries

• China

Study Locations