RecruitingNot ApplicableNCT05885828

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

Sponsor

Westlake University

Enrollment

200 participants

Start Date

Jul 17, 2023

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Min Age: 35 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether personalized nutrition plans — tailored to an individual's biology and lifestyle — can better control blood sugar in people with type 2 diabetes compared to standard dietary advice. **You may be eligible if...** - You have been diagnosed with type 2 diabetes - You have lived in Hangzhou, China for at least five years - You are willing to complete the intervention and provide samples **You may NOT be eligible if...** - You have a physical or mental disability that prevents participation - You are already vegetarian - You have cancer or serious complications from type 2 diabetes (such as kidney failure) - You have been using insulin for more than 5 years - Your medical condition or medications are currently unstable - You currently use alcohol or drugs heavily - You have taken antibiotics in the last three months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERWhite 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.

OTHERWhole 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.

BEHAVIORALPlant-based diet

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

OTHERConventional diabetic diet

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

OTHERFollow-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.