Clinical trial NCT01293604: The Influence of Daily Intake of Whole Grain Barley or Oats on Biomarkers of Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Barley
Oats
Whole grains
Cardiovascular disease
adults not taking lipid-lowering or glucoregulatory medications.
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: Kellogg Company
First posted: 2011-02-10
Enrollment: 69
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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, 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

Primary outcomes:
measure: Meal Tolerance Assessment
timeFrame: 7 hours
measure: Biomarkers of cardiovascular risk
timeFrame: After a 12 hour fast
measure: Biomarkers of oxidative stress
timeFrame: After 6 weeks of feeding
measure: Biomarkers of inflammation
timeFrame: After 6 weeks of controlled feeding
measure: Biomarkers of glucoregulatory control
timeFrame: After 6 weeks of feeding
Secondary outcomes:
measure: Genotype testing
timeFrame: After 6 weeks of controlled feeding
measure: Microarray and targeted gene expression testing
timeFrame: After 6 weeks of controlled feeding
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
affiliation: USDA Beltsville Human Nutrition Research Center
name: Janet A Novotny, PhD
role: PRINCIPAL_INVESTIGATOR
References: