Measuring Single-Serving Grain Intake

• Sponsor: USDA Beltsville Human Nutrition Research Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT03783637
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.2
• Patients Per Site Per Month: 9.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Other: Whole grain oats; Other: Whole grain wheat	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Measuring Single-Serving Grain Intake
• Actual Study Start Date: May 13, 2019
• Actual Primary Completion Date: Jun 19, 2019
• Actual Study Completion Date: Jun 19, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. Identification of unknown biomarkers of grain intake immediately after grain consumption [Day 34]

   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.

5. Identification of unknown biomarkers of grain intake a day after grain consumption [Day 35]

   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.

6. Identification of unknown biomarkers of grain intake 2 days after grain consumption [Day 36]

   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 Outcome Measures

1. Blood glucose [Days 8 and 34]

   Blood glucose will be measured. Blood glucose is reported in mmol/L.

2. Serum insulin [Days 8 and 34]

   Serum insulin will be measured. Serum insulin is reported in mIU/L.

3. Serum c-peptide [Days 8 and 34]

   Serum c-peptide will be measured. Serum c-peptide is reported in ng/ml.

4. 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.

5. Triglycerides in blood [Days 8 and 34]

   Triglycerides will be measured. Triglycerides are reported as mmol/L.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USDA-ARS Beltsville Human Nutrition Research Center	Beltsville	Maryland	United States	20705

Sponsors and Collaborators

• USDA Beltsville Human Nutrition Research Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janet Novotny, Research Physiologist, USDA Beltsville Human Nutrition Research Center
• ClinicalTrials.gov Identifier: NCT03783637
• Other Study ID Numbers: HS62 - Single Grain
• First Posted: Dec 21, 2018
• Last Update Posted: Jul 5, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 5, 2019