Westlake Precision Nutrition Study 2 (WePrecision2) (WePrecision2)

May 26, 2023 updated by: Westlake University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310058
        • Westlake University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants have completed WePrecision trial in 2021
  • Participants reside in Hangzhou
  • Participants have no traveling plans within 3 months

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: refined carbohydrate breakfast (Breakfast A)
white bread (50g) + milk powder (25g)
Other: refined carbohydrate breakfast
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.
Other Names:
  • Breakfast A
Experimental: whole grain breakfast (Breakfast B)
plain oats (35g) + milk powder (25g)
Other: whole grain breakfast
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.
Other Names:
  • Breakfast B
Experimental: Energy-restricted diet
Other: energy-restricted diet
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.
Other Names:
  • ERD
Experimental: time-restricted diet
Other: time-restricted diet
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.
Other Names:
  • TRD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood glucose profiling
Time Frame: 14 days
Real-time blood glucose fluctuations will be recorded by CGM.
14 days
Change of glucose tolerance before and after intermittent fasting
Time Frame: Day 2 and Day 13
Oral glucose tolerance test will also be conducted.
Day 2 and Day 13

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes of fecal and urine metabolomics profiling
Time Frame: Day 2 and Day 13
Fecal and urine metabolite extracts will be analyzed by performing liquid
Day 2 and Day 13
Changes of serum metabolomics profiling
Time Frame: Day 2 and Day 13
Targeted metabolomics are analyzed based on serum.
Day 2 and Day 13
Changes of interleukin-1β (IL-1β), IL-6, IL-12
Time Frame: Day 2 and Day 13
Serum inflammatory factors (including IL-1β, IL-6, and IL-12) will be tested by enzyme-linked immunosorbent assay (ELISA) in pg/mL.
Day 2 and Day 13
Changes of tumor necrosis factor-α (TNF-α)
Time Frame: Day 2 and Day 13
Serum level of TNF-α will be tested by ELISA in ng/ml.
Day 2 and Day 13
Changes of serum dopamine
Time Frame: Day 2 and Day 13
Dopamine will be analyzed by serum.
Day 2 and Day 13
Changes of lipid metabolism
Time Frame: Day 2 and Day 13
Triglyceride, cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B.
Day 2 and Day 13
Changes of weight
Time Frame: Day 2 and Day 13
Weight will be measured in kilograms.
Day 2 and Day 13
Height
Time Frame: Day 2
Height will be measured in centimeters.
Day 2
Body composition
Time Frame: Day 2
Body composition (fat mass, lean mass in kg ) are assessed by bioelectrical impedance analysis.
Day 2
Changes of both systolic and diastolic blood pressure
Time Frame: Day 2 and Day 13
Both systolic and diastolic blood pressure will be measured in mmHg.
Day 2 and Day 13
Hair
Time Frame: Day 2 and Day 13
Hair sample and the hair growth will be measured in mm.
Day 2 and Day 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Westlake University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ju-Sheng Zheng, PhD, Westlake University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230306ZJS001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings