Westlake Precision Nutrition Study

Westlake Precision Nutrition Study: Diet Challenges for Glucose Metabolism

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Overweight and Obesity
• Intervention / Treatment: Other: refined carbohydrate breakfast; Other: whole grain breakfast; Other: intermittent fasting

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.

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310024
      • Westlake University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

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 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.; 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 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.; Other Names: Breakfast B
Experimental: intermittent fasting (IF)	Other: intermittent fasting; 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.; Other Names: IF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose profiling	Real-time blood glucose fluctuations will be recorded by CGM.	14 days
Change of glucose tolerance before and after intermittent fasting	Oral glucose tolerance test will also be conducted.	Day 8 and Day 13

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain images	Brain structure and function was measured by brain magnetic resonance imaging (MRI)	at enrollment
Changes of fecal and urine metabolomics profiling	Fecal and urine metabolite extracts will be analyzed by performing liquid chromatography/quadrupole time-of-flight mass spectrometry (LC/Q-TOF/MS).	Day 1, Day 8 , Day 11 and Day 14
Changes of serum metabolomics profiling	Targeted metabolomics are analyzed based on serum.	Day 1, and Day 14
Changes of interleukin-1β (IL-1β), IL-6, IL-12	Serum inflammatory factors (including IL-1β, IL-6, and IL-12) will be tested by enzyme-linked immunosorbent assay (ELISA) in pg/mL.	Day 1, and Day 14
Changes of tumor necrosis factor-α (TNF-α)	Serum level of TNF-α will be tested by ELISA in ng/mL.	Day 1, and Day 14
Changes of serum dopamine	Dopamine will be analyzed by serum.	Day 1, and Day 14
Changes of serum 5-hydroxytryptamine	5- hydroxytryptamine will be analyzed by serum.	Day 1, and Day 14
Changes of serum gamma-aminobutyric acid	Gamma-aminobutyric acid will be analyzed by serum.	Day 1, and Day 14
Changes of lipid metabolism	Triglyceride, cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B.	Day 1, and Day 14
Changes of weight	Weight will be measured in kilograms.	Day 1, Day 8 , Day 11 and Day 14
Height	Height will be measured in centimeters.	Day 1
Body composition	Body composition (fat mass, lean mass in kg ) are assessed by bioelectrical impedance analysis.	at enrollment
Changes of both systolic and diastolic blood pressure	Both systolic and diastolic blood pressure will be measured in mmHg.	Day 1, Day 8 , Day 11 and Day 14
Electroencephalograph(EEG) N2 and P3 amplitudes	Event-related potentials (N2 and P3 amplitudes) of brain will be assessed by EEG in μV.	at enrollment

Collaborators and Investigators

• Sponsor: Westlake University
• Investigators: Principal Investigator: Ju-Sheng Zheng, PhD, Westlake University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2021
• Primary Completion (Actual): December 27, 2021
• Study Completion (Actual): July 12, 2022

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 23, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Brain; Gut Microbiome; Intermittent fasting; Glucose Metabolism; Personalized Nutrition
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: 20210802ZJS001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No