Healthy
Conditions
Keywords
Barley, Oats, Whole grains, Cardiovascular disease, adults not taking lipid-lowering or glucoregulatory medications.
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.
Interventions
OTHERDaily 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.
Sponsors
Kellogg Company
United States Department of Agriculture (USDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers of cardiovascular risk | After a 12 hour fast | Fibrinogen, factor VII, blood pressure, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, Lp(a), and lipoprotein size. |
| Biomarkers of inflammation | 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 | After 6 weeks of feeding | Glycated apolipoprotein B, hemoglobin A1c, fructosamine, insulin, glucose, leptin, adiponectin |
| Meal Tolerance Assessment | 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 oxidative stress | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microarray and targeted gene expression testing | 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. |
| Genotype testing | 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. |
Countries
United States
Outcome results
None listed