Westlake Precision Nutrition Study

NCT05054153 | Completed DMC

• 1 other identifier: 20210802ZJS001
• Study Type: interventional
• Target: 176
• 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 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.

Conditions

Healthy; Overweight and Obesity

Keywords

Glucose Metabolism; Intermittent fasting; Personalized Nutrition; Brain; Gut Microbiome

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 8 and Day 13

Other Outcomes (14)

• Changes of fecal and urine metabolomics profiling

  Day 1, Day 8 , Day 11 and Day 14

• Changes of serum metabolomics profiling

  Day 1, and Day 14

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

  Day 1, and Day 14

Study Arms (3)

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

intermittent fasting (IF)

EXPERIMENTAL

Other: intermittent fasting

Interventions

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.

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 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.

Also known as: Breakfast B

whole grain breakfast (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.

Also known as: IF

intermittent fasting (IF)

Eligibility Criteria

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

You may qualify if:

• Participants reside in Hangzhou
• Participants have no traveling plans within 3 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• Westlake University: lead

Study Sites (1)

Westlake University

Hangzhou, Zhejiang, 310024, China

Location

Related Publications (1)

• Zhang K, Fu Y, Gou W, Miao Z, Tian Y, Liang Y, Liang X, Shuai M, Xiao C, Wang J, Xu F, Jiang Z, Gao C, Ma S, Ordovas JM, Zheng JS. Quantification of personalized glycemic sensitivity to food and its potential for precision nutrition in a series of n-of-1 trials. Am J Clin Nutr. 2025 Aug;122(2):502-512. doi: 10.1016/j.ajcnut.2025.04.015. Epub 2025 Jun 19.

  PMID: 40754388 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Intermittent Fasting

Condition Hierarchy (Ancestors)

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

Study Officials

• Ju-Sheng Zheng, PhD

  Westlake University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 23, 2021
• Study Start: October 8, 2021
• Primary Completion: December 27, 2021
• Study Completion: July 12, 2022
• Last Updated: September 5, 2023

Record last verified: 2021-08

Locations

CN (1)