Healthy Volunteers
Conditions
Brief summary
The primary objective of this study is to identify markers of a single meal of 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 a single meal 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
OTHERWhole grain oats
A meal containing whole grain oats
OTHERWhole grain wheat
A meal containing whole grain wheat
Sponsors
USDA Beltsville Human Nutrition Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 21 to 75 years of age * Voluntarily agree to participate and sign an informed consent form
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 biomarkers of grain intake immediately after grain consumption | Day 8 | Blood and Urine metabolomics profiling will be conducted. Metabolomics refers to the complete set of small molecule metabolites. The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment. Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge). The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake. |
| Identification of unknown biomarkers of grain intake a day after grain consumption | Day 9 | Blood and Urine metabolomics profiling will be conducted. Metabolomics refers to the complete set of small molecule metabolites. The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment. Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge). The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake. |
| Identification of unknown biomarkers of grain intake 2 days after grain consumption | Day 10 | Urine metabolomics profiling will be conducted. Metabolomics refers to the complete set of small molecule metabolites. The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment. Urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge). The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-esterified fatty acids in blood | Days 8 and 34 | Non-esterified fatty acids will be measured in blood. Non-esterified fatty acids are reported as mEQ/L. |
| Blood glucose | Days 8 and 34 | Blood glucose will be measured. Blood glucose is reported in mmol/L. |
| Triglycerides in blood | Days 8 and 34 | Triglycerides will be measured. Triglycerides are reported as mmol/L. |
| Serum insulin | Days 8 and 34 | Serum insulin will be measured. Serum insulin is reported in mIU/L. |
| Serum c-peptide | Days 8 and 34 | Serum c-peptide will be measured. Serum c-peptide is reported in ng/ml. |
Countries
United States
Outcome results
None listed