Acute Heart Health Benefits of Whole Grain Barley and Oats in Healthy Men and Women

Cardiovascular Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283672
• Other study ID #: HS33
• Status: Completed
• Phase: N/A
• First received: January 21, 2011
• Last updated: July 15, 2011
• Start date: January 2011
• Est. completion date: April 2011

Study information

• Verified date: July 2011
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• Men and women between the ages of 25-70 years

• Body mass index (BMI) = 19 and = 38

• Willingness and ability to make scheduled appointments at clinical site as required by study protocol

Exclusion Criteria:

• Do not regularly consume breakfast or dislike cereal for breakfast

• Known (self-reported) allergy or adverse reaction to grains (e.g., wheat, gluten, barley)

• Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes

• Type 2 diabetes requiring the use of oral antidiabetic agents or insulin

• Fasting triglycerides > 300 mg/dL

• Fasting glucose > 126 mg/dL

• Use of cholesterol lowering medication

• Blood pressure > 180/100 or hypertension treated with calcium channel blockers, direct acting vasodilators, or beta blockers

• Fingernails longer than 0.25 inch beyond the finger tip, or unwillingness to cut fingernails to this length during endothelial function testing

• History of bariatric or certain other surgeries related to weight control

• History of major surgery within 3 months of enrollment

• Smokers or other tobacco users (during 6 months prior to the start of the study)

• Antibiotic use during the intervention or for 3 months prior to the intervention period

• History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)

• Volunteers who have lost 10% of body weight within the last 6 months

• Unable or unwilling to give informed consent or communicate with study staff

• Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)

• Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Other:
• Controlled diet with whole grain barley, whole grain oats, or low grain diet
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.

Locations

Country	Name	City	State
United States	US Department of Agriculture Beltsville Human Nutrition Research Center	Beltsville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
United States Department of Agriculture (USDA)	Kellogg Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid Tolerance Test	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.	After 3 consecutive days of controlled feeding.	No
Primary	EndoPAT	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.	After 3 consecutive days of controlled feeding	No
Secondary	Genetic testing	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.	After 3 consecutive days of controlled feeding	No
Secondary	Microarray and targeted gene expression testing	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.	After 3 consecutive days of controlled feeding	No