Type 2 DiabetesNCT05885828
The PRECISION-T2D Study: Precision Nutrition Study for Type 2 Diabetes
A study testing White bread, Whole wheat bread and Plant-based diet in people with Type 2 Diabetes, run by Westlake University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- White bread, Whole wheat bread and Plant-based diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesChina
- Study dates
- 17 Jul 2023to 4 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Westlake University
Hangzhou, Zhejiang, 310030
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, 310058
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- White bread, Whole wheat bread, Plant-based diet, Conventional diabetic diet, Follow-up visit every 1-2 years
- Keywords
- N-of-1, plant-based diet, precision nutrition, continuous glucose monitoring, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White breadOther
Also called Breakfast A
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.
Whole wheat breadOther
Also called Breakfast B
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.
Plant-based dietBehavioural
After wearing CGM on Day 1, participants will be asked to follow the plant-based diet in next 30 days.
Conventional diabetic dietOther
Volunteers will be asked to have a diet following 2023 Chinese Diabetes Society guidelines in next 30 days.
Follow-up visit every 1-2 yearsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: White bread; Other: Whole wheat bread; Other: Conventional diabetic diet; Other: Follow-up visit every 1-2 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous glucose monitoring-derived mean blood glucose
Real-time glucose profiles will be recorded using continuous glucose monitoring. Average of all glucose measurements during the up to 14 days CGM wear will be calculated in mmol/L.
Measured: 2 weeks
Continuous glucose monitoring-derived time-in-range
Real-time glucose profiles will be recorded using continuous glucose monitoring. Percentage of glucose measurements that wear in the range of 3.9-10.0 mmol/L during the up to 14 days CGM will be calculated.
Measured: 2 weeks
Continuous glucose monitoring-derived coefficient of variation
Continuous glucose monitoring-derived time-in-range Real-time glucose profiles will be recorded using continuous glucose monitoring. Coefficient of variation was defined as standard deviation divided by mean glucose and multiplied by 100, during the up to 14 days wear.
Measured: two weeks
Changes in gut microbiome profile
Shotgun metagenomic sequencing will be performed in stool samples.
Measured: Day 1, 15 and 31
Secondary outcomes (4)
Changes in fasting blood glucose
Fasting glucose will be examined in mmol/L.
Measured: Day 1, 15 and 31
Changes in fasting blood C-peptide
Fasting blood C-peptide will be examined in μg/L.
Measured: Day 1, 15 and 31
Changes in fasting blood HbA1c
Fasting blood HbA1c will be examined in %.
Measured: Day 1, 15 and 31
Changes in lipid metabolism
Triglyceride, cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol will be examined in mmol/L.
Measured: Day 1, 15 and 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start17 Jul 2023
- Primary completion4 Jan 2026
- Study completion4 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westlake University
- Sponsor type
- University, hospital or other
- Collaborators
- The Third People's Hospital of Hangzhou
- Responsible party
- Sponsor
- Investigators
- Ju-Sheng Zheng, PhD, Principal investigator, Westlake University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885828
- Sponsor's protocol ID
- 20230306ZJS002
- Status last verified
- Sep 2026
- First submitted
- 23 Mar 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PRECISION-T2D Study: Precision Nutrition Study for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05885828
- Acronym / sponsor ID
- 20230306ZJS002
- Conditions
- Type 2 Diabetes
- Keywords
- N-of-1, plant-based diet, precision nutrition, continuous glucose monitoring, type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Westlake UniversityUniversity, hospital or other
- Collaborators
- The Third People's Hospital of Hangzhou
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 4 Jan 2026 (actual)
- Study completion
- 4 Jan 2026 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant-based diet | Experimental | Other: White bread, Other: Whole wheat bread, Behavioral: Plant-based diet, Other: Follow-up visit every 1-2 yearsParticipants 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. |
| Conventional diabetic diet | Experimental | Other: White bread, Other: Whole wheat bread, Other: Conventional diabetic diet, Other: Follow-up visit every 1-2 yearsParticipants 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. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White breadAlso: Breakfast AAfter 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 | Conventional diabetic diet, Plant-based diet |
| Whole wheat breadAlso: Breakfast BAfter 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 | Conventional diabetic diet, Plant-based diet |
| Plant-based dietAfter wearing CGM on Day 1, participants will be asked to follow the plant-based diet in next 30 days. | Behavioural | Plant-based diet |
| Conventional diabetic dietVolunteers will be asked to have a diet following 2023 Chinese Diabetes Society guidelines in next 30 days. | Other | Conventional diabetic diet |
| Follow-up visit every 1-2 yearsParticipants 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, Plant-based diet |
Primary outcome
Continuous glucose monitoring-derived mean blood glucose
Time frame: 2 weeks
Real-time glucose profiles will be recorded using continuous glucose monitoring. Average of all glucose measurements during the up to 14 days CGM wear will be calculated in mmol/L.
Continuous glucose monitoring-derived time-in-range
Time frame: 2 weeks
Real-time glucose profiles will be recorded using continuous glucose monitoring. Percentage of glucose measurements that wear in the range of 3.9-10.0 mmol/L during the up to 14 days CGM will be calculated.
Continuous glucose monitoring-derived coefficient of variation
Time frame: two weeks
Continuous glucose monitoring-derived time-in-range Real-time glucose profiles will be recorded using continuous glucose monitoring. Coefficient of variation was defined as standard deviation divided by mean glucose and multiplied by 100, during the up to 14 days wear.
Changes in gut microbiome profile
Time frame: Day 1, 15 and 31
Shotgun metagenomic sequencing will be performed in stool samples.
4 secondary outcomes
Changes in fasting blood glucose
Time frame: Day 1, 15 and 31
Changes in fasting blood C-peptide
Time frame: Day 1, 15 and 31
Changes in fasting blood HbA1c
Time frame: Day 1, 15 and 31
Changes in lipid metabolism
Time frame: Day 1, 15 and 31
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju-Sheng Zheng, PhD principal investigator
Westlake University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White bread, Whole wheat bread and Plant-based diet in people with Type 2 Diabetes, run by Westlake University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous glucose monitoring-derived mean blood glucose (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.