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Completed

NCT Number: NCT05054153

Westlake Precision Nutrition Study

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westlake University

Hangzhou, Zhejiang, 310024, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

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 2, Day 5 and Day 6. 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 3, Day 4 and Day 7. 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

intermittent fasting

Other

The period during Day 8 to Day 13 is intermittent fasting period. Participants will experience the moderate fasting on Day 9 and Day 12, which means their daily energy intake is expected to be controlled within 500-600 kcal limit. In these two days, participants will be provided with all three meals. Percentages of macronutrients of provided meals will follow the Recommended Dietary Health guidelines for Chinese residents. The oral glucose tolerance test (OGTT) will be conducted in the morning on Day 8 and Day 13, to test short-term impact of IF intervention on individuals' glucose tolerance. The breakfasts on Day 10 and Day 11 will be the same as that in fasting days. Other meals will be wash-out meals.

Other names: IF

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 8 and Day 13

    Oral glucose tolerance test will also be conducted.

Other outcomes

  1. Changes of fecal and urine metabolomics profiling

    Time frame: Day 1, Day 8 , Day 11 and Day 14

    Fecal and urine metabolite extracts will be analyzed by performing liquid chromatography/quadrupole time-of-flight mass spectrometry (LC/Q-TOF/MS).

  2. Changes of serum metabolomics profiling

    Time frame: Day 1, and Day 14

    Targeted metabolomics are analyzed based on serum.

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

    Time frame: Day 1, and Day 14

    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 1, and Day 14

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

  5. Changes of serum dopamine

    Time frame: Day 1, and Day 14

    Dopamine will be analyzed by serum.

  6. Changes of serum 5-hydroxytryptamine

    Time frame: Day 1, and Day 14

    5- hydroxytryptamine will be analyzed by serum.

  7. Changes of serum gamma-aminobutyric acid

    Time frame: Day 1, and Day 14

    Gamma-aminobutyric acid will be analyzed by serum.

  8. Changes of lipid metabolism

    Time frame: Day 1, and Day 14

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

  9. Changes of weight

    Time frame: Day 1, Day 8 , Day 11 and Day 14

    Weight will be measured in kilograms.

  10. Height

    Time frame: Day 1

    Height will be measured in centimeters.

  11. Body composition

    Time frame: at enrollment

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

  12. Changes of both systolic and diastolic blood pressure

    Time frame: Day 1, Day 8 , Day 11 and Day 14

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

  13. Electroencephalograph(EEG) N2 and P3 amplitudes

    Time frame: at enrollment

    Event-related potentials (N2 and P3 amplitudes) of brain will be assessed by EEG in μV.

  14. Brain images

    Time frame: at enrollment

    Brain structure and function was measured by brain magnetic resonance imaging (MRI)

Sponsors and collaborators

Lead sponsor

Westlake University

Other

Registry information

Official study title

Westlake Precision Nutrition Study: Diet Challenges for Glucose Metabolism

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 23, 2021
Registry last updated
Sep 5, 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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