Clinical Trials Directory

Trials / Completed

CompletedNCT01403857

Evaluating Liking, Acceptability and Health Benefits of Grain Products

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
45 (actual)
Sponsor
USDA, Western Human Nutrition Research Center · Federal
Sex
All
Age
20 Years – 45 Years
Healthy volunteers
Accepted

Summary

The specific aims of the Grain Study are to determine if exposure to different types of grain products, over a period of 6 weeks, changes liking and acceptability and to determine if the gut microbiota, bacterial fermentation products, or gastrointestinal function changes with consumption of whole grains or refined grains.

Detailed description

Subjects will be recruited in accordance with inclusion and exclusion criteria listed below. Subjects will be assigned to one of two different grain product 'exposure' groups - Group 1 will receive predominantly Whole Grain (WG) products and Group 2 will receive predominantly Refined Grain (RG) products (ratio of WG to RG assignment will be 2:1). For a 6-week exposure period, subjects will receive weekly market baskets of grain products consisting of breakfast cereals, breads, snack items, and side dishes with the target of providing whole grains at a level of 85% of grain intake for the WG group (this exceeds the current Dietary Guideline recommendation of 50%) and 15% for the RG group (this is the current estimated intake for U.S. adults). Before and after grain exposure, subjects will rate the acceptability and liking of numerous grain products. To accomplish this, subjects will participate in sensory evaluation tests using these products, and they will provide information using validated questionnaires and take implicit association tests. During the 6-week study period, subjects will record use of the market basket grain products, and provide subjective scores for taste, convenience, nutrition, and general liking. The quality of the total dietary intake will be assessed using unannounced 24-h recalls. Biological samples will also be collected from subjects. Blood and urine samples will be collected to evaluate risk factors of chronic disease, and biomarkers of whole grain intake, fruits and vegetables. Saliva and fecal samples will be collected to measure changes in gut microbiota and to measure metabolites of bacterial fermentation. Breath hydrogen tests will be conducted to measure bacterial fermentation. Two weeks after the end of the intervention period, subjects will participate in a nominal group session to identify significant barriers and facilitators to inclusion of grain products into their diets.

Conditions

Interventions

TypeNameDescription
OTHERWhole grain foodsEight commonly consumed whole grain products that meet the consumers Dietary Guidelines recommendations for a period of six weeks.
OTHERRefined grainsEight commonly consumed refined grain products given in amounts that fulfill the consumer's Dietary Guidelines for Americans recommendation over the course of six weeks.

Timeline

Start date
2010-04-01
Primary completion
2013-10-01
Completion
2013-12-01
First posted
2011-07-27
Last updated
2024-03-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01403857. Inclusion in this directory is not an endorsement.