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NCT Number: NCT05800730

Westlake Precision Nutrition Study 2 (WePrecision2)

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.

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Key information

Conditions

Healthy Behavior Body Weight Fasting Feeding Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westlake University

Hangzhou, Zhejiang, 310058, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 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.

Other names: Breakfast B

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.

Other names: ERD

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.

Other names: TRD

Primary outcomes

  1. Blood glucose profiling

    Time frame: 14 days

    Real-time blood glucose fluctuations will be recorded by CGM.

  2. Change of glucose tolerance before and after intermittent fasting

    Time frame: Day 2 and Day 13

    Oral glucose tolerance test will also be conducted.

Other outcomes

  1. Changes of fecal and urine metabolomics profiling

    Time frame: Day 2 and Day 13

    Fecal and urine metabolite extracts will be analyzed by performing liquid

  2. Changes of serum metabolomics profiling

    Time frame: Day 2 and Day 13

    Targeted metabolomics are analyzed based on serum.

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

    Time frame: Day 2 and Day 13

    Serum inflammatory factors (including IL-1β, IL-6, and IL-12) will be tested by enzyme-linked immunosorbent assay (ELISA) in pg/mL.

  4. Changes of tumor necrosis factor-α (TNF-α)

    Time frame: Day 2 and Day 13

    Serum level of TNF-α will be tested by ELISA in ng/ml.

  5. Changes of serum dopamine

    Time frame: Day 2 and Day 13

    Dopamine will be analyzed by serum.

  6. Changes of lipid metabolism

    Time frame: Day 2 and Day 13

    Triglyceride, cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B.

  7. Changes of weight

    Time frame: Day 2 and Day 13

    Weight will be measured in kilograms.

  8. Height

    Time frame: Day 2

    Height will be measured in centimeters.

  9. Body composition

    Time frame: Day 2

    Body composition (fat mass, lean mass in kg ) are assessed by bioelectrical impedance analysis.

  10. Changes of both systolic and diastolic blood pressure

    Time frame: Day 2 and Day 13

    Both systolic and diastolic blood pressure will be measured in mmHg.

  11. Hair

    Time frame: Day 2 and Day 13

    Hair sample and the hair growth will be measured in mm.

Sponsors and collaborators

Lead sponsor

Westlake University

Other

Registry information

Official study title

Westlake Precision Nutrition Study 2 : Diet Challenges for Glucose Metabolism

Acronym: WePrecision2

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 6, 2023
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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