Westlake Precision Nutrition Study 2 (WePrecision2)

Healthy Clinical Trial

— WePrecision2  

Official title:

Westlake Precision Nutrition Study 2 : Diet Challenges for Glucose Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05800730
• Other study ID #: 20230306ZJS001
• Status: Completed
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: May 19, 2023

Study information

• Verified date: March 2023
• Source: Westlake University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 19, 2023
• Est. primary completion date: May 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Overweight
• Overweight and Obesity

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Westlake University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Westlake University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes of fecal and urine metabolomics profiling	Fecal and urine metabolite extracts will be analyzed by performing liquid	Day 2 and Day 13
Other	Changes of serum metabolomics profiling	Targeted metabolomics are analyzed based on serum.	Day 2 and Day 13
Other	Changes of interleukin-1ß (IL-1ß), IL-6, IL-12	Serum inflammatory factors (including IL-1ß, IL-6, and IL-12) will be tested by enzyme-linked immunosorbent assay (ELISA) in pg/mL.	Day 2 and Day 13
Other	Changes of tumor necrosis factor-a (TNF-a)	Serum level of TNF-a will be tested by ELISA in ng/ml.	Day 2 and Day 13
Other	Changes of serum dopamine	Dopamine will be analyzed by serum.	Day 2 and Day 13
Other	Changes of lipid metabolism	Triglyceride, cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B.	Day 2 and Day 13
Other	Changes of weight	Weight will be measured in kilograms.	Day 2 and Day 13
Other	Height	Height will be measured in centimeters.	Day 2
Other	Body composition	Body composition (fat mass, lean mass in kg ) are assessed by bioelectrical impedance analysis.	Day 2
Other	Changes of both systolic and diastolic blood pressure	Both systolic and diastolic blood pressure will be measured in mmHg.	Day 2 and Day 13
Other	Hair	Hair sample and the hair growth will be measured in mm.	Day 2 and Day 13
Primary	Blood glucose profiling	Real-time blood glucose fluctuations will be recorded by CGM.	14 days
Primary	Change of glucose tolerance before and after intermittent fasting	Oral glucose tolerance test will also be conducted.	Day 2 and Day 13