Westlake Precision Nutrition Study

Healthy Clinical Trial

Official title:

Westlake Precision Nutrition Study: Diet Challenges for Glucose Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05054153
• Other study ID #: 20210802ZJS001
• Status: Completed
• Phase: N/A
• Start date: October 8, 2021
• Est. completion date: July 12, 2022

Study information

• Verified date: August 2021
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: July 12, 2022
• Est. primary completion date: December 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

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 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.
• 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.
• 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.

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 chromatography/quadrupole time-of-flight mass spectrometry (LC/Q-TOF/MS).	Day 1, Day 8 , Day 11 and Day 14
Other	Changes of serum metabolomics profiling	Targeted metabolomics are analyzed based on serum.	Day 1, and Day 14
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 1, and Day 14
Other	Changes of tumor necrosis factor-a (TNF-a)	Serum level of TNF-a will be tested by ELISA in ng/mL.	Day 1, and Day 14
Other	Changes of serum dopamine	Dopamine will be analyzed by serum.	Day 1, and Day 14
Other	Changes of serum 5-hydroxytryptamine	5- hydroxytryptamine will be analyzed by serum.	Day 1, and Day 14
Other	Changes of serum gamma-aminobutyric acid	Gamma-aminobutyric acid will be analyzed by serum.	Day 1, and Day 14
Other	Changes of lipid metabolism	Triglyceride, cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B.	Day 1, and Day 14
Other	Changes of weight	Weight will be measured in kilograms.	Day 1, Day 8 , Day 11 and Day 14
Other	Height	Height will be measured in centimeters.	Day 1
Other	Body composition	Body composition (fat mass, lean mass in kg ) are assessed by bioelectrical impedance analysis.	at enrollment
Other	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
Other	Electroencephalograph(EEG) N2 and P3 amplitudes	Event-related potentials (N2 and P3 amplitudes) of brain will be assessed by EEG in µV.	at enrollment
Other	Brain images	Brain structure and function was measured by brain magnetic resonance imaging (MRI)	at enrollment
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 8 and Day 13