Measuring Daily Grain Intake Study

Study Overview
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Brief Summary
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The primary objective of this study is to identify markers of daily 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 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.

Official Title
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Measuring Daily Grain Intake Study

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: Control Refined Grain Diet
* Other: Low Whole Grain Oat Diet
* Other: High Whole Grain Oat Diet
* Other: Low Whole Grain Wheat Diet
* Other: High Whole Grain Wheat Diet


Participation Criteria
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Eligibility Criteria
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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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Volunteers will consume a diet in which all grain foods are made from refined grains. | Other: Control Refined Grain Diet<br>* Subjects will be fed the average American diet except it will be free of whole grains<br>|
| Experimental: Low Whole Grain Oat Diet<br>Volunteers will consume a diet with a low level of whole grain oat incorporated into some of the foods. | Other: Low Whole Grain Oat Diet<br>* Subjects will be fed the average American diet with addition of a low level of whole grain oats<br>|
| Experimental: High Whole Grain Oat Diet<br>Volunteers will consume a diet with a high level of whole grain oat incorporated into some of the foods. | Other: High Whole Grain Oat Diet<br>* Subjects will be fed the average American diet with addition of a high level of whole grain oats<br>|
| Experimental: Low Whole Grain Wheat Diet<br>Volunteers will consume a diet with a low level of whole grain wheat incorporated into some of the foods. | Other: Low Whole Grain Wheat Diet<br>* Subjects will be fed the average American diet with addition of a low level of whole grain wheat<br>|
| Experimental: High Whole Grain Wheat Diet<br>Volunteers will consume a diet with a high level of whole grain wheat incorporated into some of the foods. | Other: High Whole Grain Wheat Diet<br>* Subjects will be fed the average American diet with addition of a high level of 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 blood biomarkers of grain intake | 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 | Day 1 of Period 1 (period = 15 days) | 
| Identification of unknown blood biomarkers of grain intake | 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 | Day 1 of Period 2 (period = 15 days) | 
| Identification of unknown blood biomarkers of grain intake | 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 | Day 1 of Period 3 (period = 15 days) | 
| Identification of unknown blood biomarkers of grain intake | 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 | Day 1 of Period 4 (period = 15 days) | 
| Identification of unknown blood biomarkers of grain intake | 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 | Day 1 of Period 5 (period = 15 days) | 
| Identification of unknown blood biomarkers of grain intake | 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 | Day 8 of Period 1 (period = 15 days) | 
| Identification of unknown blood biomarkers of grain intake | 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 | Day 8 of Period 2 (period = 15 days) | 
| Identification of unknown blood biomarkers of grain intake | 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 | Day 8 of Period 3 (period = 15 days) | 
| Identification of unknown blood biomarkers of grain intake | 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 | Day 8 of Period 4 (period = 15 days) | 
| Identification of unknown blood biomarkers of grain intake | 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 | Day 8 of Period 5 (period = 15 days) | 
| Identification of unknown blood biomarkers of grain intake | 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 | Day 15 of Period 1 (period = 15 days) | 
| Identification of unknown blood biomarkers of grain intake | 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 | Day 15 of Period 2 (period = 15 days) | 
| Identification of unknown blood biomarkers of grain intake | 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 | Day 15 of Period 3 (period = 15 days) | 
| Identification of unknown blood biomarkers of grain intake | 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 | Day 15 of Period 4 (period = 15 days) | 
| Identification of unknown blood biomarkers of grain intake | 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 | Day 15 of Period 5 (period = 15 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of unknown urinary biomarkers of grain intake | 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 | Day 1, 8, and 15 of each of the 5 fifteen day diet periods | 
| Characterization of fecal microbiota | Fecal samples will be analyzed for microbiota | Day 1, 8, and 15 of each of the 5 fifteen day diet periods | 
| Blood Glucose | Fasting blood glucose will be measured in mg/dL | Day 1 and 15 of each of the 5 fifteen day diet periods | 
| Blood Insulin | Fasting blood insulin will be measured in uIU/mL | Day 1 and 15 of each of the 5 fifteen day diet periods | 
| Blood Triglycerides | Fasting blood triglycerides will be measured in mg/dL | Day 1 and 15 of each of the 5 fifteen day diet periods | 
| Blood Non-Esterified Fatty Acids | Fasting blood non esterified fatty acids will be measured in mEQ/L | Day 1 and 15 of each of the 5 fifteen day diet periods |