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Trial record 9 of 54 for:    barley

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

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ClinicalTrials.gov Identifier: NCT01293604
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : October 14, 2011
Sponsor:
Collaborator:
Kellogg Company
Information provided by:
USDA Beltsville Human Nutrition Research Center

Tracking Information
First Submitted Date  ICMJE February 8, 2011
First Posted Date  ICMJE February 10, 2011
Last Update Posted Date October 14, 2011
Study Start Date  ICMJE May 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2011)
  • Meal Tolerance Assessment [ Time Frame: 7 hours ]
    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 ]
    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 ]
    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 ]
    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 ]
    Glycated apolipoprotein B, hemoglobin A1c, fructosamine, insulin, glucose, leptin, adiponectin
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01293604 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2011)
  • Genotype testing [ Time Frame: After 6 weeks 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 [ Time Frame: After 6 weeks 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. Targeted gene expression will be performed to confirm the findings of the global gene expression analysis.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Influence of Daily Intake of Whole Grain Barley or Oats on Biomarkers of Cardiovascular Disease
Official Title  ICMJE Not Provided
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Whole Grain Barley Diet
    A controlled diet containing at least 4 daily servings of whole grain barley.
    Intervention: Other: Daily ingestion of whole grain barley and oats
  • Active Comparator: Whole Grain Oats Diet
    A diet containing at least 4 servings of whole grain oats.
    Intervention: Other: Daily ingestion of whole grain barley and oats
  • Low Whole Grain Diet
    A control diet containing 0.7 daily servings of whole grain.
    Intervention: Other: Daily ingestion of whole grain barley and oats
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 9, 2011)
69
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01293604
Other Study ID Numbers  ICMJE HS34
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janet A. Novotny, USDA
Study Sponsor  ICMJE United States Department of Agriculture (USDA)
Collaborators  ICMJE Kellogg Company
Investigators  ICMJE
Principal Investigator: Janet A Novotny, PhD USDA Beltsville Human Nutrition Research Center
PRS Account USDA Beltsville Human Nutrition Research Center
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP