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Westlake Precision Nutrition Study

Primary Purpose

Healthy, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
refined carbohydrate breakfast
whole grain breakfast
intermittent fasting
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 Glucose Metabolism, Intermittent fasting, Personalized Nutrition, Brain, Gut Microbiome

Eligibility Criteria

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

Inclusion Criteria:

  • Participants reside in Hangzhou
  • Participants have no traveling plans within 3 months

Exclusion Criteria:

  • Refusing or unable to give informed consent
  • Participants with chronic gastrointestinal diseases and take daily relevant medications
  • 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 Type

Experimental

Experimental

Experimental

Arm Label

refined carbohydrate breakfast (Breakfast A)

whole grain breakfast (Breakfast B)

intermittent fasting (IF)

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
August 24, 2021
Last Updated
August 31, 2023
Sponsor
Westlake University
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1. Study Identification

Unique Protocol Identification Number
NCT05054153
Brief Title
Westlake Precision Nutrition Study
Official Title
Westlake Precision Nutrition Study: Diet Challenges for Glucose Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 8, 2021 (Actual)
Primary Completion Date
December 27, 2021 (Actual)
Study Completion Date
July 12, 2022 (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 intermittent fasting (IF) 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 explore differences in brain structure and function between participants with different Body Mass Index (BMI) from the perspective of gut-brain axis.
Detailed Description
This study aims for precision nutrition. 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. Individual N-of-1 trial design will be employed during Day 2 to Day 7 to compare the difference of postprandial glucose response to white bread or plain oats. These two breakfasts will appear in alternating order every successive 2 days, and these successive 2 days will be defined as one set. There will be 3 sets during Day 2 to Day 7. Between lunch and dinner will be the wash out period for the remaining effect of the last breakfast intervention on blood glucose homeostasis. In this period, participants will be allowed to choose foods without restrictions, but dietary records are required. The period during Day 8 to Day 14 is defined as intermittent fasting (IF) period, and participants will experience moderate fasting on Day 9 and Day 13 with total energy intake restrained within 500-600 kcal. In these two fasting days, participants will be provided with daily three meals. Investigators will closely monitor participants' latent adverse response and compliance to ensure the intervention will be completed with adequate safety and high compliancy. Oral glucose tolerance test (OGTT) will be conducted in the morning of Day 8 and Day 14 to test the changes of glucose tolerance before and after one set of IF intervention. Electroencephalogram (EEG) and functional Magnetic Resonance Imaging (fMRI) scanning will be conducted as per standard procedure at baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Overweight and Obesity
Keywords
Glucose Metabolism, Intermittent fasting, Personalized Nutrition, Brain, Gut Microbiome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (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
intermittent fasting (IF)
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 2, Day 5 and Day 6. 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 3, Day 4 and Day 7. 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)
intermittent fasting
Other Intervention Name(s)
IF
Intervention Description
The period during Day 8 to Day 13 is intermittent fasting period. Participants will experience the moderate fasting on Day 9 and Day 12, which means their daily energy intake is expected to be controlled within 500-600 kcal limit. In these two days, participants will be provided with all three meals. Percentages of macronutrients of provided meals will follow the Recommended Dietary Health guidelines for Chinese residents. The oral glucose tolerance test (OGTT) will be conducted in the morning on Day 8 and Day 13, to test short-term impact of IF intervention on individuals' glucose tolerance. The breakfasts on Day 10 and Day 11 will be the same as that in fasting days. Other meals will be wash-out meals.
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 8 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 chromatography/quadrupole time-of-flight mass spectrometry (LC/Q-TOF/MS).
Time Frame
Day 1, Day 8 , Day 11 and Day 14
Title
Changes of serum metabolomics profiling
Description
Targeted metabolomics are analyzed based on serum.
Time Frame
Day 1, and Day 14
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 1, and Day 14
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 1, and Day 14
Title
Changes of serum dopamine
Description
Dopamine will be analyzed by serum.
Time Frame
Day 1, and Day 14
Title
Changes of serum 5-hydroxytryptamine
Description
5- hydroxytryptamine will be analyzed by serum.
Time Frame
Day 1, and Day 14
Title
Changes of serum gamma-aminobutyric acid
Description
Gamma-aminobutyric acid will be analyzed by serum.
Time Frame
Day 1, and Day 14
Title
Changes of lipid metabolism
Description
Triglyceride, cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B.
Time Frame
Day 1, and Day 14
Title
Changes of weight
Description
Weight will be measured in kilograms.
Time Frame
Day 1, Day 8 , Day 11 and Day 14
Title
Height
Description
Height will be measured in centimeters.
Time Frame
Day 1
Title
Body composition
Description
Body composition (fat mass, lean mass in kg ) are assessed by bioelectrical impedance analysis.
Time Frame
at enrollment
Title
Changes of both systolic and diastolic blood pressure
Description
Both systolic and diastolic blood pressure will be measured in mmHg.
Time Frame
Day 1, Day 8 , Day 11 and Day 14
Title
Electroencephalograph(EEG) N2 and P3 amplitudes
Description
Event-related potentials (N2 and P3 amplitudes) of brain will be assessed by EEG in μV.
Time Frame
at enrollment
Title
Brain images
Description
Brain structure and function was measured by brain magnetic resonance imaging (MRI)
Time Frame
at enrollment

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 reside in Hangzhou Participants have no traveling plans within 3 months Exclusion Criteria: Refusing or unable to give informed consent Participants with chronic gastrointestinal diseases and take daily relevant medications 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
310024
Country
China

12. IPD Sharing Statement

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Westlake Precision Nutrition Study

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