A Dose-response Study to Validate the Biomarkers for Whole Grain Dietary Intake

Peking University

Status: Completed

Conditions: Chronic Disease Prevention

Treatments: Other: Whole grain wheat flour

Study type: Interventional

Funder types: Other

Identifiers

NCT06358781

xuyajun197673-002

Details and patient eligibility

About

Dose-response validation of whole grain dietary intake biomarkers remains limited, and it is debatable whether these markers could be utilized as classifiers for different levels of whole grain consumption. Because there are significant disparities in genetic background and dietary patterns between Chinese and Western cultures, it is unclear if whole grain dietary intake biomarkers can characterize whole grain consumption in Chinese populations. To address these issues, the current study was designed to evaluate the sensitivity and specificity of potential whole grain markers in a randomized controlled trial, as well as to validate the markers' dose-response relationship, so that they can be used in nutritional epidemiological studies and dietary intake assessments of whole grains.

Full description

An acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour administered were 0 g, 25g, 50 g and 100 g. Experimental period with a total of 6 days was subdivided into two parts: -5 days to 0 h defined as the run-in period, 0-24 h (after the dose-related test meal), defined as the test day.

Enrollment: 38 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: Parallel Assignment

Masking: None (Open label)

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38 participants in 4 patient groups

Group A (WG wheat flour intake= 0 g)

No Intervention group

Description:

An acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour for group A were 0 g.

Group B (WG wheat flour intake= 25 g)

Experimental group

Description:

An acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour for group B were 25 g.

Treatment:

Other: Whole grain wheat flour

Group C (WG wheat flour intake= 50 g)

Experimental group

Description:

An acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour for group C were 50 g.

Treatment:

Other: Whole grain wheat flour

Group D (WG wheat flour intake= 100 g)

Experimental group

Description:

An acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour for group D were 100 g.

Treatment:

Other: Whole grain wheat flour