Western Human Nutrition Research Center
Davis, California, 95616, United States
NCT Number: NCT01403857
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.
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Notify Me20 year–45 year
All sexes
Interventional
Not applicable
Davis, California, 95616, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Eight commonly consumed whole grain products that meet the consumers Dietary Guidelines recommendations for a period of six weeks.
Eight commonly consumed refined grain products given in amounts that fulfill the consumer's Dietary Guidelines for Americans recommendation over the course of six weeks.
Time frame: 0, 6 weeks
Sensory evaluation of grain products
Time frame: 0, 6 weeks
To determine if gut microbiota change over the intervention and if those changes persist over the long term. Gut microbiota assessed using 16S methodology.
Time frame: 0, 6 weeks
Change in gastrointestinal function assessed using a questionnaire and exhaled breath hydrogen (ppm).
Time frame: 0, 6 weeks
Implicit Attitude Tests assessed using a calculated D score using the method described by Greenwald et al.
USDA, Western Human Nutrition Research Center
Fed
Acronym: FL75
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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