Healthy Volunteers
Conditions
Brief summary
The primary objective of this study is to identify markers of daily whole grain oat and whole grain wheat intake in humans.
Detailed description
The aim of this study is to identify compounds that are found in blood and urine and are derived from repeated daily consumption of whole grain oat or whole grain wheat intake so that epidemiological studies can be conducted to provide more accurate associations between whole grain intake and health.
Interventions
OTHERControl Refined Grain Diet
Subjects will be fed the average American diet except it will be free of whole grains
OTHERLow Whole Grain Oat Diet
Subjects will be fed the average American diet with addition of a low level of whole grain oats
OTHERHigh Whole Grain Oat Diet
Subjects will be fed the average American diet with addition of a high level of whole grain oats
OTHERLow Whole Grain Wheat Diet
Subjects will be fed the average American diet with addition of a low level of whole grain wheat
OTHERHigh Whole Grain Wheat Diet
Subjects will be fed the average American diet with addition of a high level of whole grain wheat
Sponsors
United States Department of Agriculture (USDA)
USDA Beltsville Human Nutrition Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 21 - 75 years * non smokers
Exclusion criteria
* Body weight less than 110 lbs. * Have a body mass index below 19 or above 38 kg/m2 * Known (self-reported) allergy or adverse reaction to study foods * Women who have given birth during the previous 12 months or who are pregnant/lactating or who plan to become pregnant during the study * History of bariatric surgery or nutrient malabsorption disease (such as celiac disease), Crohn's disease, diabetes, or metabolic disorders that may interfere with the study * History of certain cancer diagnosis or treatment in the last 3 years * Smoking or use of tobacco products in the past 6 months * Suspected or known strictures, fistulas or physiological/mechanical GI obstruction * Use of certain medications or supplements (prescription or over-the-counter) that may interfere with the study objectives, including blood thinning medications * 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 treatment 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 |
|---|---|---|
| Identification of unknown blood biomarkers of grain intake | Day 1 of Period 1 (period = 15 days) | Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of unknown urinary biomarkers of grain intake | Day 1, 8, and 15 of each of the 5 fifteen day diet periods | Metabolomic analysis of urine samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined |
| Blood Glucose | Day 1 and 15 of each of the 5 fifteen day diet periods | Fasting blood glucose will be measured in mg/dL |
| Characterization of fecal microbiota | Day 1, 8, and 15 of each of the 5 fifteen day diet periods | Fecal samples will be analyzed for microbiota |
| Blood Triglycerides | Day 1 and 15 of each of the 5 fifteen day diet periods | Fasting blood triglycerides will be measured in mg/dL |
| Blood Non-Esterified Fatty Acids | Day 1 and 15 of each of the 5 fifteen day diet periods | Fasting blood non esterified fatty acids will be measured in mEQ/L |
| Blood Insulin | Day 1 and 15 of each of the 5 fifteen day diet periods | Fasting blood insulin will be measured in uIU/mL |
Countries
United States
Outcome results
None listed