Measuring Single-Serving Grain Intake

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Whole grain oats; Other: Whole grain wheat

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Beltsville, Maryland, United States, 20705
      • USDA-ARS Beltsville Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: USDA Beltsville Human Nutrition Research Center

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2019
• Primary Completion (Actual): June 19, 2019
• Study Completion (Actual): June 19, 2019

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 21, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HS62 - Single Grain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No