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

NCT01293604 | Completed DMC

• 1 other identifier: HS34
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Barley; Oats; Whole grains; Cardiovascular disease; adults not taking lipid-lowering or glucoregulatory medications.

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• Biomarkers of inflammation

  C-reactive protein (CRP), IL-6, IL-8, IL-10, IL-18, TNFα, matrix metalloproteinases (MMP-2, MMP-9), e-Selectin, ICAM, VCAM

  After 6 weeks of controlled feeding

• Biomarkers of glucoregulatory control

  Glycated apolipoprotein B, hemoglobin A1c, fructosamine, insulin, glucose, leptin, adiponectin

  After 6 weeks of feeding

Secondary Outcomes (2)

• Genotype testing

  After 6 weeks of controlled feeding

• Microarray and targeted gene expression testing

  After 6 weeks of controlled feeding

Study Arms (3)

Whole Grain Barley Diet

EXPERIMENTAL

A controlled diet containing at least 4 daily servings of whole grain barley.

Other: Daily ingestion of whole grain barley and oats

Whole Grain Oats Diet

ACTIVE COMPARATOR

A diet containing at least 4 servings of whole grain oats.

Other: Daily ingestion of whole grain barley and oats

Low Whole Grain Diet

OTHER

A control diet containing 0.7 daily servings of whole grain.

Other: Daily ingestion of whole grain barley and oats

Interventions

Daily ingestion of whole grain barley and oats OTHER

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; Whole Grain Barley Diet; Whole Grain Oats Diet

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Department of Agriculture (USDA): lead
• Kellogg Company: collaborator

Study Sites (1)

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Janet A Novotny, PhD

  USDA Beltsville Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: February 8, 2011
• First Posted: February 10, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 14, 2011

Record last verified: 2011-10

Locations

US (1)