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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

49

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Westlake University

Investigators

  • 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)

May 8, 2023

Primary Completion (Actual)

May 19, 2023

Study Completion (Actual)

May 19, 2023

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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