The Human Metabolic Profile and Gut Microbiota Under Various Dietary Quality

Peking University

Status: Completed

Conditions: Biomarkers

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05837858

xuyajun197673

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

Other: whole grain-wheat flour food+standardized meals

Other: refined wheat flour food+standardized meals