The Human Metabolic Profile and Gut Microbiota Under Various Dietary Quality
- Conditions
- Biomarkers
- Interventions
- Other: whole grain-wheat flour food+standardized mealsOther: refined wheat flour food+standardized meals
- Registration Number
- NCT05837858
- Lead Sponsor
- Peking University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Healthy men and women
- age 18-40 years
- BMI 18.5-23.9 kg/m2.
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description whole grain-wheat flour food, then refined wheat flour food whole grain-wheat flour food+standardized meals 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. whole grain-wheat flour food, then refined wheat flour food refined wheat flour food+standardized meals 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. refined wheat flour food, then whole grain-wheat flour food whole grain-wheat flour food+standardized meals 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. refined wheat flour food, then whole grain-wheat flour food refined wheat flour food+standardized meals 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.
- Primary Outcome Measures
Name Time Method Changes in metabolite profiles present in blood plasma and urine before the dietary intervention and in kinetics over 24 hours. Baseline and 0-24 hours after intervention food intake 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.
- Secondary Outcome Measures
Name Time Method The influence of gut flora on whole grain markers after the administration of the test meal Gut flora abundance and metabolites level correlation analysis
Trial Locations
- Locations (1)
Department of Nutrition and Food Hygiene, School of Public Health, Peking University
🇨🇳Beijing, China