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Westlake Precision Nutrition Study 2 (WePrecision2) (WePrecision2)

Primary Purpose

Healthy, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
refined carbohydrate breakfast
whole grain breakfast
energy-restricted diet
time-restricted diet
Sponsored by
Westlake University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy focused on measuring Personalized Nutrition, N-of-1, fasting, glucose metabolism, hair growth

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Westlake University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

refined carbohydrate breakfast (Breakfast A)

whole grain breakfast (Breakfast B)

Energy-restricted diet

time-restricted diet

Arm Description

white bread (50g) + milk powder (25g)

plain oats (35g) + milk powder (25g)

Outcomes

Primary Outcome Measures

Blood glucose profiling
Real-time blood glucose fluctuations will be recorded by CGM.
Change of glucose tolerance before and after intermittent fasting
Oral glucose tolerance test will also be conducted.

Secondary Outcome Measures

Full Information

First Posted
March 23, 2023
Last Updated
May 26, 2023
Sponsor
Westlake University
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1. Study Identification

Unique Protocol Identification Number
NCT05800730
Brief Title
Westlake Precision Nutrition Study 2 (WePrecision2)
Acronym
WePrecision2
Official Title
Westlake Precision Nutrition Study 2 : Diet Challenges for Glucose Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
May 19, 2023 (Actual)
Study Completion Date
May 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Westlake University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Overweight and Obesity
Keywords
Personalized Nutrition, N-of-1, fasting, glucose metabolism, hair growth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
refined carbohydrate breakfast (Breakfast A)
Arm Type
Experimental
Arm Description
white bread (50g) + milk powder (25g)
Arm Title
whole grain breakfast (Breakfast B)
Arm Type
Experimental
Arm Description
plain oats (35g) + milk powder (25g)
Arm Title
Energy-restricted diet
Arm Type
Experimental
Arm Title
time-restricted diet
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
refined carbohydrate breakfast
Other Intervention Name(s)
Breakfast A
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
whole grain breakfast
Other Intervention Name(s)
Breakfast B
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
energy-restricted diet
Other Intervention Name(s)
ERD
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
time-restricted diet
Other Intervention Name(s)
TRD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood glucose profiling
Description
Real-time blood glucose fluctuations will be recorded by CGM.
Time Frame
14 days
Title
Change of glucose tolerance before and after intermittent fasting
Description
Oral glucose tolerance test will also be conducted.
Time Frame
Day 2 and Day 13
Other Pre-specified Outcome Measures:
Title
Changes of fecal and urine metabolomics profiling
Description
Fecal and urine metabolite extracts will be analyzed by performing liquid
Time Frame
Day 2 and Day 13
Title
Changes of serum metabolomics profiling
Description
Targeted metabolomics are analyzed based on serum.
Time Frame
Day 2 and Day 13
Title
Changes of interleukin-1β (IL-1β), IL-6, IL-12
Description
Serum inflammatory factors (including IL-1β, IL-6, and IL-12) will be tested by enzyme-linked immunosorbent assay (ELISA) in pg/mL.
Time Frame
Day 2 and Day 13
Title
Changes of tumor necrosis factor-α (TNF-α)
Description
Serum level of TNF-α will be tested by ELISA in ng/ml.
Time Frame
Day 2 and Day 13
Title
Changes of serum dopamine
Description
Dopamine will be analyzed by serum.
Time Frame
Day 2 and Day 13
Title
Changes of lipid metabolism
Description
Triglyceride, cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B.
Time Frame
Day 2 and Day 13
Title
Changes of weight
Description
Weight will be measured in kilograms.
Time Frame
Day 2 and Day 13
Title
Height
Description
Height will be measured in centimeters.
Time Frame
Day 2
Title
Body composition
Description
Body composition (fat mass, lean mass in kg ) are assessed by bioelectrical impedance analysis.
Time Frame
Day 2
Title
Changes of both systolic and diastolic blood pressure
Description
Both systolic and diastolic blood pressure will be measured in mmHg.
Time Frame
Day 2 and Day 13
Title
Hair
Description
Hair sample and the hair growth will be measured in mm.
Time Frame
Day 2 and Day 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ju-Sheng Zheng, PhD
Organizational Affiliation
Westlake University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westlake University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310058
Country
China

12. IPD Sharing Statement

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Westlake Precision Nutrition Study 2 (WePrecision2)

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