Westlake Precision Nutrition Study 2 (WePrecision2)

Westlake University

Status: Completed

Conditions: Healthy; Overweight and Obesity

Treatments: Other: refined carbohydrate breakfast; Other: time-restricted diet; Other: whole grain breakfast; Other: energy-restricted diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05800730

20230306ZJS001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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49 participants in 4 patient groups

refined carbohydrate breakfast (Breakfast A)

Experimental group

Description:

white bread (50g) + milk powder (25g)

Treatment:

Other: refined carbohydrate breakfast

whole grain breakfast (Breakfast B)

Experimental group

Description:

plain oats (35g) + milk powder (25g)

Treatment:

Other: whole grain breakfast

Energy-restricted diet

Experimental group

Treatment:

Other: energy-restricted diet

time-restricted diet

Experimental group

Treatment:

Other: time-restricted diet