Measuring Single-Serving Grain Intake

Study Overview
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Brief Summary
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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
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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.

Official Title
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Measuring Single-Serving Grain Intake

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: Whole grain oats
* Other: Whole grain wheat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Whole Grain Oat<br>Volunteers will consume a breakfast meal containing whole grain oats after 7 days of a whole grain free diet. | Other: Whole grain oats<br>* A meal containing whole grain oats<br>|
| Other: Whole Grain Wheat<br>Volunteers will consume a breakfast meal containing whole grain wheat after 7 days of a whole grain free diet. | Other: Whole grain wheat<br>* A meal containing whole grain wheat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of unknown biomarkers of grain intake immediately after grain consumption | 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. | Day 8 | 
| Identification of unknown biomarkers of grain intake a day after grain consumption | 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. | Day 9 | 
| Identification of unknown biomarkers of grain intake 2 days after grain consumption | 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. | Day 10 | 
| Identification of unknown biomarkers of grain intake immediately after grain consumption | 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. | Day 34 | 
| Identification of unknown biomarkers of grain intake a day after grain consumption | 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. | Day 35 | 
| Identification of unknown biomarkers of grain intake 2 days after grain consumption | 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. | Day 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose | Blood glucose will be measured. Blood glucose is reported in mmol/L. | Days 8 and 34 | 
| Serum insulin | Serum insulin will be measured. Serum insulin is reported in mIU/L. | Days 8 and 34 | 
| Serum c-peptide | Serum c-peptide will be measured. Serum c-peptide is reported in ng/ml. | Days 8 and 34 | 
| Non-esterified fatty acids in blood | Non-esterified fatty acids will be measured in blood. Non-esterified fatty acids are reported as mEQ/L. | Days 8 and 34 | 
| Triglycerides in blood | Triglycerides will be measured. Triglycerides are reported as mmol/L. | Days 8 and 34 |