The Human Metabolic Profile and Gut Microbiota Under Various Dietary Quality

NCT ID: NCT05837858

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-28
• Study Completion Date: 2023-05-24

Brief Summary

The goal of this food intervention study is to screen/validate the whole grain food intake biomarker in health Chinese's population.

Detailed Description

Although increased consumption of whole grains (WGs) is associated with improved health outcomes, the dietary intake assessment and health mechanisms for WGs or WG-containing food remain unresolved. In addition, information regarding its consumption and health effects in Chinese people is scarce. Biomarkers of WGs intake would allow a more accurate assessment of its consumption in nutrition studies. The investigators want to perform a crossover study where participants were subjected to a WG-wheat flour or a refine wheat-flour Chinese diet. Using a metabolomics approach, the investigators aimed to identify the WG-specific metabolites present in plasma/urine after consumption WG or WG foods, including new candidate biomarkers of WG intake.

Conditions

Biomarkers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

whole grain-wheat flour food, then refined wheat flour food

Participants first received food made by 50 g whole grain wheat flour during breakfast in a fasting state. Standardized meals were provided to the volunteers from the dinner of the day before the intervention day, as well as up to 48 h after the administration of the test food. After a washout period of 5 days, volunteers followed a 2-day restricted diet before the intervention day. Participants then received food made by 50 g refined grain wheat flour in a fasting state.

Group Type: EXPERIMENTAL

whole grain-wheat flour food+standardized meals

Intervention Type: OTHER

whole grain food made by 50 g whole grain wheat flour

refined wheat flour food+standardized meals

Intervention Type: OTHER

refined grain food made by 50 g refined wheat flour

refined wheat flour food, then whole grain-wheat flour food

Participants first received food made by 50 g refined grain wheat flour during breakfast in a fasting state. Standardized meals were provided to the volunteers from the dinner of the day before the intervention day, as well as up to 48 h after the administration of the test food. After a washout period of 5 days, volunteers followed a 2-day restricted diet before the intervention day. Participants then received food made by 50 g whole grain wheat flour in a fasting state.

Group Type: EXPERIMENTAL

whole grain-wheat flour food+standardized meals

Intervention Type: OTHER

whole grain food made by 50 g whole grain wheat flour

refined wheat flour food+standardized meals

Intervention Type: OTHER

refined grain food made by 50 g refined wheat flour

Interventions

whole grain-wheat flour food+standardized meals

whole grain food made by 50 g whole grain wheat flour

Intervention Type: OTHER

refined wheat flour food+standardized meals

refined grain food made by 50 g refined wheat flour

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy men and women
• age 18-40 years
• BMI 18.5-23.9 kg/m2.

Exclusion Criteria

• pregnancy or breastfeeding
• vegetarian;
• smokers;
• acute and chronic diseases;
• allergic to wheat;
• frequent nutrients supplement use;
• medication use of antibiotics within 1-month;
• more than 3 kg weight change within 3-month;
• unwillingness to follow dietary restrictions;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yunjia yang

Role: PRINCIPAL_INVESTIGATOR

Peking University

Yalin Zhou

Role: PRINCIPAL_INVESTIGATOR

Peking University

Locations

Department of Nutrition and Food Hygiene, School of Public Health, Peking University

Beijing, , China

Countries

China

Other Identifiers

xuyajun197673

Identifier Type: -

Identifier Source: org_study_id