US Department of Agriculture Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705, United States
NCT Number: NCT01283672
The objectives of this study are the following: 1) to determine the acute effect of whole grain barley on risk factors of cardiovascular disease compared to a diet low in whole grain, and 2) to compare the effects of whole grain barley to those of whole grain oats to determine if the response to these two grains is similar.
Looking for future studies?
Notify Me25 year–70 year
All sexes
Interventional
Not applicable
Beltsville, Maryland, 20705, United States
Whole grains contain bioactive components that may contribute to reduced risk of cardiovascular disease, and there may be significant differences among whole grain sources with respect to ability to alter biomarkers of cardiovascular disease. This acute study is designed to determine if whole grain barley improves postprandial lipid metabolism and improves endothelial function. Further, we will determine if acute consumption of whole grain barley versus acute consumption of whole grain oats results in differential response with respect to biomarkers of cardiovascular disease risk.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will consume a standardized diet for 3 days prior to the treatment intervention meal. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. Participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda.
Time frame: After 3 consecutive days of controlled feeding.
Participants will come in after a 12-hour fast for a lipid tolerance test. Specifically, participants will consume a treatment breakfast meal and blood samples will be collected 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, and 420 minutes following ingestion of the treatment meal.
Time frame: After 3 consecutive days of controlled feeding
Endothelial function will be assessed by measuring endothelium-dependent flow mediated dilation of the peripheral bed (EndoPAT, Itamar Medical, Israel). Immediately after the test, a blood sample will be collected for measurement of serum triglycerides.
Time frame: After 3 consecutive days of controlled feeding
Blood will be used to test for genetic traits that may influence nutrient metabolism and also traits reflecting the mechanisms that may be influenced by the intervention.
Time frame: After 3 consecutive days of controlled feeding
Blood samples will be used to test how the intervention affects gene expression. Global gene expression will be performed for a complete survey of the RNA response to the intervention, and targeted gene expression will be performed to confirm the findings of the global gene expression analysis.
United States Department of Agriculture (USDA)
Fed
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.
Published trials that share one or more normalized conditions with this study.
NCT07738250
Cancer Survivorship, Cardiovascular Disease
View Trial DetailsNCT01778569
Cardiovascular Disease, Cardiovascular Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT02840448
Aortic Stenosis, Supravalvular, Aortic Valve Disease
Bethesda, Maryland, United States
View Trial DetailsNCT01934660
Cardiovascular Disease, Cardiovascular Diseases
Bethesda, Maryland, United States
View Trial Details