The Human Metabolic Profile and Gut Microbiota Under Various Dietary Quality

NCT05837858 | Completed

• 1 other identifier: xuyajun197673
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Biomarkers

Keywords

Food biomarker; Whole grain; Chinese population

Outcome Measures

Primary Outcomes (1)

• Changes in metabolite profiles present in blood plasma and urine before the dietary intervention and in kinetics over 24 hours.

  Metabolite profiles analyzed using a non-targeted metabolomics approach and targeted metabolomics approach with a Orbitrap Mass Analyzer. Blood plasma samples collected at time 0 hours, 2 hours, 4 hours, and 24 hours. Urine fractions collected at 0-2 hours, 2-4 hours, 4-6 hours, 6-9 hours, 9-12 hours, 12-24 hours and 24-48 hours. Identification of biomarkers of acute intake of the foods of interest through the comparison of specific metabolomes after single dose of WG food or refined grain food in Chinese population.

  Baseline and 0-24 hours after intervention food intake

Secondary Outcomes (1)

• The influence of gut flora on whole grain markers

  after the administration of the test meal

Study Arms (2)

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

EXPERIMENTAL

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.

Other: whole grain-wheat flour food+standardized meals; Other: refined wheat flour food+standardized meals

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

EXPERIMENTAL

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.

Other: whole grain-wheat flour food+standardized meals; Other: refined wheat flour food+standardized meals

Interventions

whole grain-wheat flour food+standardized meals OTHER

whole grain food made by 50 g whole grain wheat flour

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

refined wheat flour food+standardized meals OTHER

refined grain food made by 50 g refined wheat flour

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

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

Beijing, China

Location

Study Officials

• Yunjia yang

  Peking University

  PRINCIPAL INVESTIGATOR

• Yalin Zhou

  Peking University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomized Crossover Assignment

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 1, 2023
• Study Start: April 28, 2023
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: December 30, 2023
• Access Criteria: In a publication

Locations

CN (1)