HealthyWePrecision2NCT05800730
Westlake Precision Nutrition Study 2 (WePrecision2)
A study testing refined carbohydrate breakfast, whole grain breakfast and energy-restricted diet in people with Healthy and Overweight and Obesity, run by Westlake University at 1 site in China.
Trial summary
This is a dietary intervention study, which aims to explore different diet challenges for glucose metabolism, including carbohydrates and fasting dietary pattern. Considering the glucose responses to the same food are largely heterogeneous among people, this study integrates the concepts of precision nutrition and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Overweight and Obesity
- What is being tested?
- refined carbohydrate breakfast, whole grain breakfast and energy-restricted diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2023to 19 May 2023
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants have completed WePrecision trial in 2021
- Participants reside in Hangzhou
- Participants have no traveling plans within 3 months
Who cannot join
- Participants with metabolic diseases including diabetes, hypertension and cardiovascular diseases (CVD)
- Participants with craniocerebral trauma, cancer, liver disease, kidney disease, or other critical illness, or history of operation or medication
- Participants with bulimia nervosa, post-traumatic stress disorder (PTSD), chronic anxiety and depression or other critical neuronal disorder or history of relevant medication
- Being or to be pregnant or lactating.
- Participants with history of alcohol or drug addiction, or smoke above 15 cigarettes per day
- Concurrently participating other clinical trials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Westlake Precision Nutrition Study 2 : Diet Challenges for Glucose Metabolism
This is a dietary intervention study, which aims to explore different diet challenges for glucose metabolism, including carbohydrates and fasting dietary pattern. Considering the glucose responses to the same food are largely heterogeneous among people, this study integrates the concepts of precision nutrition and N-of-1 design. The study also aims to discover the different impact of the time-restricted diet (TRD) and the energy-restricted diet (ERD) on host metabolic health and our hair growth.
Read the detailed description
The project is mainly based on classic field trial study design to compare impacts of different fasting patterns on host metabolic health. Under the condition of controlled diet background, individual N-of-1 study design is also organically integrated to compare personalized responses for standard meal tests. Participants will be required to wear continuous glucose monitoring (CGM) for 14 days. The diet intervention will be carried out after wearing CGM on Day 1. Then, all participants will be divided into three groups: energy-restricted diet (ERD), 18:6 time-restricted diet (TRD), and normal diet (ND). During Day 3 to Day 12, ERD restricts daily total energy intake within 1200-1500 kcal without meal timing limits, while TRD restricts the daily feeding window from 10:00 to 16:00, without total energy intake restriction. ND will maintain volunteers' original eating habits and rhythms as the control group. Individual N-of-1 trial design will be employed to all participants during Day 3 to Day 12 to compare the difference of postprandial glucose response to white bread or plain oats. These two standard breakfasts will appear in pseudo-random order. The TRD group needs to adjust the breakfast time to after 10:00 in the intervention periods.
- Conditions
- Healthy, Overweight and Obesity
- Being tested
- refined carbohydrate breakfast, whole grain breakfast, energy-restricted diet, time-restricted diet
- Keywords
- Personalized Nutrition, N-of-1, fasting, glucose metabolism, hair growth
- Medical subject headings
- Overweight, Obesity, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
refined carbohydrate breakfastOther
Also called Breakfast A
After wearing CGM on Day 1, participants will be provided with breakfast A once daily on Day 3, Day 4, Day 7, Day 8, Day 10, Day 12. Breakfast A contains white bread (50g) and milk powder (25g). Since lunch and dinner would serve as wash-out meals, participants will be free to choose food but provide a record of their diets.
whole grain breakfastOther
Also called Breakfast B
After wearing CGM on Day 1, participants will be provided with Breakfast B once daily on Day 5, Day 6, Day 9, Day 11. Breakfast B contains plain oats (35g) and milk powder (25g). Since lunch and dinner would serve as wash-out meals, participants will be free to choose food but provide a record of their diets.
energy-restricted dietOther
Also called ERD
After completing the baseline data and biological sample collection, the ERD group volunteers underwent a 10-day dietary intervention from day 3 to day 12. During this period, a standard breakfast was provided to all volunteers daily by the research staff through the school cafeteria. The ERD group volunteers still had their lunch and dinner provided by the research staff through the school cafeteria to ensure their daily energy intake was controlled between 1200-1500 kcal.
time-restricted dietOther
Also called TRD
After completing the baseline data and biological sample collection, the volunteers in the TRD group will undergo a 10-day dietary intervention from day 3 to day 12. The TRD group needs to adjust their breakfast eating time to after 10:00 am daily, and they are free to choose their own lunch and dinner according to their dietary habits but must finish their meals before 4:00 pm. During this time window, no other energy-providing foods should be consumed.
| Study group | Role | What they receive |
|---|---|---|
| refined carbohydrate breakfast (Breakfast A) | Experimental | white bread (50g) + milk powder (25g) Receives: Other: refined carbohydrate breakfast |
| whole grain breakfast (Breakfast B) | Experimental | plain oats (35g) + milk powder (25g) Receives: Other: whole grain breakfast |
| Energy-restricted diet | Experimental | Not described Receives: Other: energy-restricted diet |
| time-restricted diet | Experimental | Not described Receives: Other: time-restricted diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose profiling
Real-time blood glucose fluctuations will be recorded by CGM.
Measured: 14 days
Change of glucose tolerance before and after intermittent fasting
Oral glucose tolerance test will also be conducted.
Measured: Day 2 and Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start8 May 2023
- Primary completion19 May 2023
- Study completion19 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westlake University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ju-Sheng Zheng, PhD, Principal investigator, Westlake University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800730
- Sponsor's protocol ID
- 20230306ZJS001
- Acronym
- WePrecision2
- Status last verified
- Mar 2023
- First submitted
- 23 Mar 2023
- Last updated
- 31 May 2023
- 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 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Westlake Precision Nutrition Study 2 : Diet Challenges for Glucose Metabolism
- ClinicalTrials.gov ID
- NCT05800730
- Acronym / sponsor ID
- WePrecision2 / 20230306ZJS001
- Conditions
- Healthy, Overweight and Obesity
- Keywords
- Personalized Nutrition, N-of-1, fasting, glucose metabolism, hair growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Westlake UniversityUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 19 May 2023 (actual)
- Study completion
- 19 May 2023 (actual)
- First posted
- 6 Apr 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.
This is a dietary intervention study, which aims to explore different diet challenges for glucose metabolism, including carbohydrates and fasting dietary pattern. Considering the glucose responses to the same food are largely heterogeneous among people, this study integrates the concepts of precision nutrition and N-of-1 design. The study also aims to discover the different impact of the time-restricted diet (TRD) and the energy-restricted diet (ERD) on host metabolic health and our hair growth.
Detailed description
The project is mainly based on classic field trial study design to compare impacts of different fasting patterns on host metabolic health. Under the condition of controlled diet background, individual N-of-1 study design is also organically integrated to compare personalized responses for standard meal tests. Participants will be required to wear continuous glucose monitoring (CGM) for 14 days. The diet intervention will be carried out after wearing CGM on Day 1. Then, all participants will be divided into three groups: energy-restricted diet (ERD), 18:6 time-restricted diet (TRD), and normal diet (ND). During Day 3 to Day 12, ERD restricts daily total energy intake within 1200-1500 kcal without meal timing limits, while TRD restricts the daily feeding window from 10:00 to 16:00, without total energy intake restriction. ND will maintain volunteers' original eating habits and rhythms as the control group. Individual N-of-1 trial design will be employed to all participants during Day 3 to Day 12 to compare the difference of postprandial glucose response to white bread or plain oats. These two standard breakfasts will appear in pseudo-random order. The TRD group needs to adjust the breakfast time to after 10:00 in the intervention periods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| refined carbohydrate breakfast (Breakfast A) | Experimental | Other: refined carbohydrate breakfastwhite bread (50g) + milk powder (25g) |
| whole grain breakfast (Breakfast B) | Experimental | Other: whole grain breakfastplain oats (35g) + milk powder (25g) |
| Energy-restricted diet | Experimental | Other: energy-restricted diet |
| time-restricted diet | Experimental | Other: time-restricted diet |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants have completed WePrecision trial in 2021
- Participants reside in Hangzhou
- Participants have no traveling plans within 3 months
Key exclusion criteria (6 listed)
- Participants with metabolic diseases including diabetes, hypertension and cardiovascular diseases (CVD)
- Participants with craniocerebral trauma, cancer, liver disease, kidney disease, or other critical illness, or history of operation or medication
- Participants with bulimia nervosa, post-traumatic stress disorder (PTSD), chronic anxiety and depression or other critical neuronal disorder or history of relevant medication
- Being or to be pregnant or lactating.
- Participants with history of alcohol or drug addiction, or smoke above 15 cigarettes per day
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 |
|---|---|---|
| refined carbohydrate breakfastAlso: Breakfast AAfter wearing CGM on Day 1, participants will be provided with breakfast A once daily on Day 3, Day 4, Day 7, Day 8, Day 10, Day 12. Breakfast A contains white bread (50g) and milk powder (25g). Since lunch and dinner would serve as wash-out meals, participants will be free to choose food but provide a record of their diets. | Other | refined carbohydrate breakfast (Breakfast A) |
| whole grain breakfastAlso: Breakfast BAfter wearing CGM on Day 1, participants will be provided with Breakfast B once daily on Day 5, Day 6, Day 9, Day 11. Breakfast B contains plain oats (35g) and milk powder (25g). Since lunch and dinner would serve as wash-out meals, participants will be free to choose food but provide a record of their diets. | Other | whole grain breakfast (Breakfast B) |
| energy-restricted dietAlso: ERDAfter completing the baseline data and biological sample collection, the ERD group volunteers underwent a 10-day dietary intervention from day 3 to day 12. During this period, a standard breakfast was provided to all volunteers daily by the research staff through the school cafeteria. The ERD group volunteers still had their lunch and dinner provided by the research staff through the school cafeteria to ensure their daily energy intake was controlled between 1200-1500 kcal. | Other | Energy-restricted diet |
| time-restricted dietAlso: TRDAfter completing the baseline data and biological sample collection, the volunteers in the TRD group will undergo a 10-day dietary intervention from day 3 to day 12. The TRD group needs to adjust their breakfast eating time to after 10:00 am daily, and they are free to choose their own lunch and dinner according to their dietary habits but must finish their meals before 4:00 pm. During this time window, no other energy-providing foods should be consumed. | Other | time-restricted diet |
Primary outcome
Blood glucose profiling
Time frame: 14 days
Real-time blood glucose fluctuations will be recorded by CGM.
Change of glucose tolerance before and after intermittent fasting
Time frame: Day 2 and Day 13
Oral glucose tolerance test will also be conducted.
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 31 May 2023.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing refined carbohydrate breakfast, whole grain breakfast and energy-restricted diet in people with Healthy and Overweight and Obesity, run by Westlake University at 1 site 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 6 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 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Blood glucose profiling (time frame: 14 days). The study lists 2 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 31 May 2023.