Westlake Precision Nutrition Study 2 (WePrecision2)

NCT05800730 | Completed DMC

• 1 other identifier: 20230306ZJS001
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Overweight and Obesity

Keywords

Personalized Nutrition; N-of-1; fasting; glucose metabolism; hair growth

Outcome Measures

Primary Outcomes (2)

• 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 2 and Day 13

Other Outcomes (11)

• Changes of fecal and urine metabolomics profiling

  Day 2 and Day 13

• Changes of serum metabolomics profiling

  Day 2 and Day 13

• Changes of interleukin-1β (IL-1β), IL-6, IL-12

  Day 2 and Day 13

Study Arms (4)

refined carbohydrate breakfast (Breakfast A)

EXPERIMENTAL

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

Other: refined carbohydrate breakfast

whole grain breakfast (Breakfast B)

EXPERIMENTAL

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

Other: whole grain breakfast

Energy-restricted diet

EXPERIMENTAL

Other: energy-restricted diet

time-restricted diet

EXPERIMENTAL

Other: time-restricted diet

Interventions

energy-restricted diet OTHER

After completing the baseline data and biological sample collection, the ERD group volunteers underwent a 10-day dietary intervention from day 3 to day 12. During this period, a standard breakfast was provided to all volunteers daily by the research staff through the school cafeteria. The ERD group volunteers still had their lunch and dinner provided by the research staff through the school cafeteria to ensure their daily energy intake was controlled between 1200-1500 kcal.

Also known as: ERD

Energy-restricted diet

refined carbohydrate breakfast OTHER

After wearing CGM on Day 1, participants will be provided with breakfast A once daily on Day 3, Day 4, Day 7, Day 8, Day 10, Day 12. 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.

Also known as: Breakfast A

refined carbohydrate breakfast (Breakfast A)

whole grain breakfast OTHER

After wearing CGM on Day 1, participants will be provided with Breakfast B once daily on Day 5, Day 6, Day 9, Day 11. 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.

Also known as: Breakfast B

whole grain breakfast (Breakfast B)

time-restricted diet OTHER

After completing the baseline data and biological sample collection, the volunteers in the TRD group will undergo a 10-day dietary intervention from day 3 to day 12. The TRD group needs to adjust their breakfast eating time to after 10:00 am daily, and they are free to choose their own lunch and dinner according to their dietary habits but must finish their meals before 4:00 pm. During this time window, no other energy-providing foods should be consumed.

Also known as: TRD

time-restricted diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants have completed WePrecision trial in 2021
• Participants reside in Hangzhou
• Participants have no traveling plans within 3 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• Westlake University: lead

Study Sites (1)

Westlake University

Hangzhou, Zhejiang, 310058, China

Location

MeSH Terms

Conditions

Overweight; Obesity; Fasting

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Ju-Sheng Zheng, PhD

  Westlake University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 6, 2023
• Study Start: May 8, 2023
• Primary Completion: May 19, 2023
• Study Completion: May 19, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-03

Locations

CN (1)