Clinical trial NCT05054153: Westlake Precision Nutrition Study
Official title: Westlake Precision Nutrition Study: Diet Challenges for Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Overweight and Obesity
Keywords: Glucose Metabolism
Intermittent fasting
Personalized Nutrition
Brain
Gut Microbiome
Lead sponsor: Westlake University
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Blood glucose profiling
timeFrame: 14 days
measure: Change of glucose tolerance before and after intermittent fasting
timeFrame: Day 8 and Day 13
Secondary outcomes:
Other outcomes:
measure: Changes of fecal and urine metabolomics profiling
timeFrame: Day 1, Day 8 , Day 11 and Day 14
measure: Changes of serum metabolomics profiling
timeFrame: Day 1, and Day 14
measure: Changes of interleukin-1β (IL-1β), IL-6, IL-12
timeFrame: Day 1, and Day 14
measure: Changes of tumor necrosis factor-α (TNF-α)
timeFrame: Day 1, and Day 14
measure: Changes of serum dopamine
timeFrame: Day 1, and Day 14
measure: Changes of serum 5-hydroxytryptamine
timeFrame: Day 1, and Day 14
measure: Changes of serum gamma-aminobutyric acid
timeFrame: Day 1, and Day 14
measure: Changes of lipid metabolism
timeFrame: Day 1, and Day 14
measure: Changes of weight
timeFrame: Day 1, Day 8 , Day 11 and Day 14
measure: Height
timeFrame: Day 1
measure: Body composition
timeFrame: at enrollment
measure: Changes of both systolic and diastolic blood pressure
timeFrame: Day 1, Day 8 , Day 11 and Day 14
measure: Electroencephalograph(EEG) N2 and P3 amplitudes
timeFrame: at enrollment
measure: Brain images
timeFrame: at enrollment
Locations:
city: Hangzhou
country: China
facility: Westlake University
state: Zhejiang
Study officials:
affiliation: Westlake University
name: Ju-Sheng Zheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: