Clinical trial NCT05800730: Westlake Precision Nutrition Study 2 (WePrecision2)
Official title: Westlake Precision Nutrition Study 2 : Diet Challenges for Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Overweight and Obesity
Keywords: Personalized Nutrition
N-of-1
fasting
glucose metabolism
hair growth
Lead sponsor: Westlake University
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 49
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 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood glucose profiling
timeFrame: 14 days
measure: Change of glucose tolerance before and after intermittent fasting
timeFrame: Day 2 and Day 13
Secondary outcomes:
Other outcomes:
measure: Changes of fecal and urine metabolomics profiling
timeFrame: Day 2 and Day 13
measure: Changes of serum metabolomics profiling
timeFrame: Day 2 and Day 13
measure: Changes of interleukin-1β (IL-1β), IL-6, IL-12
timeFrame: Day 2 and Day 13
measure: Changes of tumor necrosis factor-α (TNF-α)
timeFrame: Day 2 and Day 13
measure: Changes of serum dopamine
timeFrame: Day 2 and Day 13
measure: Changes of lipid metabolism
timeFrame: Day 2 and Day 13
measure: Changes of weight
timeFrame: Day 2 and Day 13
measure: Height
timeFrame: Day 2
measure: Body composition
timeFrame: Day 2
measure: Changes of both systolic and diastolic blood pressure
timeFrame: Day 2 and Day 13
measure: Hair
timeFrame: Day 2 and Day 13
Locations:
city: Hangzhou
country: China
facility: Westlake University
state: Zhejiang
Study officials:
affiliation: Westlake University
name: Ju-Sheng Zheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: