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

NCT01283672 | Completed DMC

• 1 other identifier: HS33
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Disease

Keywords

Whole grains; Barley; Oats; Cardiovascular disease; Postprandial lipid metabolism; Endothelial function; Risk of cardiovascular disease in healthy men and women

Outcome Measures

Primary Outcomes (2)

• Lipid Tolerance Test

  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.

  After 3 consecutive days of controlled feeding.

• EndoPAT

  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.

  After 3 consecutive days of controlled feeding

Secondary Outcomes (2)

• Genetic testing

  After 3 consecutive days of controlled feeding

• Microarray and targeted gene expression testing

  After 3 consecutive days of controlled feeding

Interventions

Controlled diet with whole grain barley, whole grain oats, or low grain diet OTHER

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.

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, 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

Sponsors & Collaborators

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

Study Sites (1)

US Department of Agriculture Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• David J Baer, PhD

  US Department of Agriculture

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: FED

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 26, 2011
• Study Start: January 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 18, 2011

Record last verified: 2011-07

Locations

US (1)