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

United States Department of Agriculture (USDA)

Status: Completed

Conditions: Healthy

Treatments: Other: Daily ingestion of whole grain barley and oats

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT01293604

HS34

Details and patient eligibility

About

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.

Enrollment: 69 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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69 participants in 3 patient groups

Whole Grain Barley Diet

Experimental group

Description:

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

Treatment:

Other: Daily ingestion of whole grain barley and oats

Whole Grain Oats Diet

Active Comparator group

Description:

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

Treatment:

Other: Daily ingestion of whole grain barley and oats

Low Whole Grain Diet

Other group

Description:

A control diet containing 0.7 daily servings of whole grain.

Treatment:

Other: Daily ingestion of whole grain barley and oats