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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: White bread; Other: Whole wheat bread; Behavioral: Plant-based diet; Other: Follow-up visit every 1-2 years; Other: Conventional diabetic diet

Detailed Description

Choice of design: The study is a two-arm intervention study integrated with N-of-1 design.

Study population: Patients with type 2 diabetes.

Screening Assessment: Prospective participants will be selected based on the pre-defined inclusion and exclusion criteria. Recruitment will be done over the phone and via the social media.

Study duration: Each participant will take part in the study for a period of up to 1 month at baseline and have follow-up visits every 1-2 years.

Dietary intervention:

The PRECISION-T2D is a dietary intervention study. Upon admission, patients will be randomly assigned to two groups: plant-based diet and conventional diabetic diet. Throughout the hospitalization, all participants (n=200) will be given standardized meals. A dietitian will design the diet for both plant-based and conventional diabetic diet groups following 2023 Chinese Diabetes Society guidelines. Both diets comprised approximately 50-65% of energy from carbohydrates, 20-30% of energy from fat, 15-20% from protein. The plant-based diet had higher fiber content (25-30g) compared to the conventional diabetic diet (15-20g). Participants will be asked to consume the entire amount of food indicated for the standardized meals and to record any leftover food. All participants will be asked to track their meals, snacks and drinks with instructions on how to record their daily dietary information. Participants will also be advised not to modify their exercise habits during the course of the study. Upon discharge, Participants in the plant-based diet 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. Participants in the conventional diabetic diet arm will be recommended to have a diet following 2023 Chinese Diabetes Society guidelines. Individual N-of-1 trial design will be employed to all participants during day one to day twelve to compare the difference of postprandial glucose response to white bread or whole wheat bread. These two standard breakfasts will appear in pseudo-random order. During the participants' first baseline visit day, they will be asked to complete a baseline questionnaire to collect information on their lifestyle, dietary habits, history of medications, sleep quality and appetite. Anthropometric measurements, ultrasonography evaluation, and laboratory tests will be taken using standard protocols. Participants will then be asked to wear a continuous glucose monitor (CGM) for 14-day blood glucose monitoring, which will be done by a nurse. On day 14, participants will be asked to come in for a clinical visit where they will receive their CGM report and provide blood, saliva, urine and stool samples. On day 30, participants will be asked to come in for another clinical visit where they will provide blood, saliva, urine and stool samples.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ju-Sheng Zheng, PhD; Phone Number: 86-0571-88112056; Email: zhengjusheng@westlake.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310030
      • Recruiting
      • Westlake University
      • Contact: Zelei Miao, PhD; Phone Number: 86-0571-88112056; Email: miaozelei@westlake.edu.cn
      • Principal Investigator: Ju-Sheng Zheng, PhD
      • Contact: Hang He, Master; Phone Number: 86-0571-88112056; Email: hehang@westlake.edu.cn
    • Hangzhou, Zhejiang, China, 310058
      • Recruiting
      • Hangzhou Third people's Hospital
      • Contact: Peng Li, Master
      • Contact: Yu Chen, Master
      • Principal Investigator: Peng Li, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Plant-based diet; 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; 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 Names: Breakfast A; 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.; Other Names: Breakfast B; 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: 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.
Experimental: Conventional diabetic diet; 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; 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 Names: Breakfast A; 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.; Other Names: Breakfast B; 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.; Other: Conventional diabetic diet; Volunteers will be asked to have a diet following 2023 Chinese Diabetes Society guidelines in next 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carotid plaque	Grade carotid plaque using ultrasound.	At enrollment
Carotid intima-media thickness	Measure of carotid intima-media thickness using ultrasound.	At enrollment
Number of participants with chronic kidney disease	The serum creatine and urine creatine and protein will be measured and chronic kidney disease will be defined as an estimated glomerular filtration rate of <60 mL/min/1.73 m2 or and the presence of an elevated urine microalbumin/creatinine ratio. All cases will be verified by medical record review.	Up to 10 years
Cognitive function	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.	Up to 10 years
Changes in fasting blood glucose	Fasting glucose will be examined in mmol/L.	Day 1 and Day 31
Changes in fasting blood C-peptide	Fasting blood C-peptide will be examined in μg/L.	Day 1 and Day 31
Changes in fasting blood HbA1c	Fasting blood HbA1c will be examined in %.	Day 1 and Day 31
Changes in lipid metabolism	Triglyceride, cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol will be examined in mmol/L.	Day 1 and Day 31

Collaborators and Investigators

• Sponsor: Westlake University
• Collaborators: The Third People's Hospital of Hangzhou
• Investigators: Principal Investigator: Ju-Sheng Zheng, PhD, Westlake University

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 1, 2033

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: type 2 diabetes; N-of-1; continuous glucose monitoring; plant-based diet; precision nutrition
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 20230306ZJS002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No