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

This study has been completed.
Sponsor:
Collaborator:
Kellogg Company
Information provided by:
USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01283672
First received: January 21, 2011
Last updated: July 15, 2011
Last verified: July 2011
  Purpose

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 Intervention
Cardiovascular Disease
Other: Controlled diet with whole grain barley, whole grain oats, or low grain diet

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

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

Primary Outcome Measures:
  • Lipid Tolerance Test [ Time Frame: After 3 consecutive days of controlled feeding. ] [ Designated as safety issue: No ]
    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 [ Time Frame: After 3 consecutive days of controlled feeding ] [ Designated as safety issue: No ]
    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 [ Time Frame: After 3 consecutive days 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 3 consecutive days 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, and targeted gene expression will be performed to confirm the findings of the global gene expression analysis.


Estimated Enrollment: 18
Study Start Date: January 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  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, 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283672

Locations
United States, Maryland
US Department of Agriculture Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Sponsors and Collaborators
USDA Beltsville Human Nutrition Research Center
Kellogg Company
Investigators
Principal Investigator: David J Baer, PhD US Department of Agriculture
  More Information

No publications provided

Responsible Party: David J. Baer, USDA
ClinicalTrials.gov Identifier: NCT01283672     History of Changes
Other Study ID Numbers: HS33
Study First Received: January 21, 2011
Last Updated: July 15, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by USDA Beltsville Human Nutrition Research Center:
Whole grains
Barley
Oats
Cardiovascular disease
Postprandial lipid metabolism
Endothelial function
Risk of cardiovascular disease in healthy men and women

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014