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

This study has been completed.
Sponsor:
Collaborator:
Kellogg Company
Information provided by:
USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01293604
First received: February 8, 2011
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Healthy
Other: Daily ingestion of whole grain barley and oats

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Further study details as provided by USDA Beltsville Human Nutrition Research Center:

Primary Outcome Measures:
  • Meal Tolerance Assessment [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
    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.

  • Biomarkers of cardiovascular risk [ Time Frame: After a 12 hour fast ] [ Designated as safety issue: No ]
    Fibrinogen, factor VII, blood pressure, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, Lp(a), and lipoprotein size.

  • Biomarkers of oxidative stress [ Time Frame: After 6 weeks of feeding ] [ Designated as safety issue: No ]
    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.

  • Biomarkers of inflammation [ Time Frame: After 6 weeks of controlled feeding ] [ Designated as safety issue: No ]
    C-reactive protein (CRP), IL-6, IL-8, IL-10, IL-18, TNFα, matrix metalloproteinases (MMP-2, MMP-9), e-Selectin, ICAM, VCAM

  • Biomarkers of glucoregulatory control [ Time Frame: After 6 weeks of feeding ] [ Designated as safety issue: No ]
    Glycated apolipoprotein B, hemoglobin A1c, fructosamine, insulin, glucose, leptin, adiponectin


Secondary Outcome Measures:
  • Genotype testing [ Time Frame: After 6 weeks of controlled feeding ] [ Designated as safety issue: No ]
    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 [ Time Frame: After 6 weeks of controlled feeding ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 69
Study Start Date: May 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Whole Grain Barley Diet
A controlled diet containing at least 4 daily servings of whole grain barley.
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.
Active Comparator: Whole Grain Oats Diet
A diet containing at least 4 servings of whole grain oats.
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.
Low Whole Grain Diet
A control diet containing 0.7 daily servings of whole grain.
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.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293604

Locations
United States, Maryland
USDA Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Sponsors and Collaborators
USDA Beltsville Human Nutrition Research Center
Kellogg Company
Investigators
Principal Investigator: Janet A Novotny, PhD USDA Beltsville Human Nutrition Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Janet A. Novotny, USDA
ClinicalTrials.gov Identifier: NCT01293604     History of Changes
Other Study ID Numbers: HS34
Study First Received: February 8, 2011
Last Updated: October 13, 2011
Health Authority: United States: Federal Government

Keywords provided by USDA Beltsville Human Nutrition Research Center:
Barley
Oats
Whole grains
Cardiovascular disease
adults not taking lipid-lowering or glucoregulatory medications.

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014