The Influence of Daily Intake of Whole Grain Barley or Oats on Biomarkers of Cardiovascular Disease

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293604
• Other study ID #: HS34
• Status: Completed
• Phase: N/A
• First received: February 8, 2011
• Last updated: October 13, 2011
• Start date: May 2011
• Est. completion date: August 2011

Study information

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

Clinical Trial Summary

The objectives of this study are the following: 1) to determine the effect of daily consumption of whole grain barley for six week on risk factors of cardiovascular disease compared to a diet low in whole grains, and 2) to compare the effects of daily consumption of whole grain barley to those of whole grain oats for six weeks to determine if the response to these two grains is different.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: August 2011
• Est. primary completion date: August 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, untreated or unstable hypothyroidism, untreated or unstable hyperthyroidism, 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

• 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: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Healthy

Intervention

Other:
• Daily ingestion of whole grain barley and oats
Subjects will be randomly assigned to one of three treatments: 1) a control diet containing 0.7 daily servings of whole grain, 2) a diet containing at least 4 daily servings of whole grain barley or 3) a diet containing at least 4 servings of whole grain oats. After 6 weeks, risk factors of cardiovascular disease will be assessed after a 12 hr fast. During the seventh week, risk factors of cardiovascular disease will be assessed in the postprandial state.

Locations

Country	Name	City	State
United States	USDA 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	Meal Tolerance Assessment	Subjects will provide a baseline blood sample at 15 minutes and 5 minutes prior to consuming a test meal. Subjects will then consume a high fat breakfast of foods such as eggs, buttered English muffins, and donuts. Blood samples will be collected 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, and 420 min following ingestion of the test meal. Measurements will be made for serum triglyceride area under the curve, serum cholesterol, insulin, glucose, and plasma apo B48.	7 hours	No
Primary	Biomarkers of cardiovascular risk	Fibrinogen, factor VII, blood pressure, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, Lp(a), and lipoprotein size.	After a 12 hour fast	No
Primary	Biomarkers of oxidative stress	Nitrites and nitrates, malondialdehyde, lipid hydroperoxides, ox-LDL, resistance of LDL to Cu2+-induced oxidation, FRAP, glutathione, glutathione-S-transferase, super oxide dismutase, PON-1, betaine, homocysteine, total thiols, urinary isoprostanes.	After 6 weeks of feeding	No
Primary	Biomarkers of inflammation	C-reactive protein (CRP), IL-6, IL-8, IL-10, IL-18, TNFa, matrix metalloproteinases (MMP-2, MMP-9), e-Selectin, ICAM, VCAM	After 6 weeks of controlled feeding	No
Primary	Biomarkers of glucoregulatory control	Glycated apolipoprotein B, hemoglobin A1c, fructosamine, insulin, glucose, leptin, adiponectin	After 6 weeks of feeding	No
Secondary	Genotype 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 6 weeks 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. Targeted gene expression will be performed to confirm the findings of the global gene expression analysis.	After 6 weeks of controlled feeding	No

External Links

•   Beltsville Human Nutrition Research Center Studies Website