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

Sponsor

United States Department of Agriculture (USDA) (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT01283672

Collaborator

Kellogg Company (Industry)

Enrollment

Location

Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Other: Controlled diet with whole grain barley, whole grain oats, or low grain diet	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Outcome Measures

Primary Outcome Measures

Lipid Tolerance Test [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.
EndoPAT [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.

Secondary Outcome Measures

Genetic testing [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.
Microarray and targeted gene expression testing [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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