Measuring Single-Serving Grain Intake

Healthy Volunteers Clinical Trial

Official title:

Measuring Single-Serving Grain Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03783637
• Other study ID #: HS62 - Single Grain
• Status: Completed
• Phase: N/A
• Start date: May 13, 2019
• Est. completion date: June 19, 2019

Study information

• Verified date: July 2019
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 19, 2019
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Whole grain oats
A meal containing whole grain oats
• Whole grain wheat
A meal containing whole grain wheat

Locations

Country	Name	City	State
United States	USDA-ARS Beltsville Human Nutrition Research Center	Beltsville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Blood glucose	Blood glucose will be measured. Blood glucose is reported in mmol/L.	Days 8 and 34
Secondary	Serum insulin	Serum insulin will be measured. Serum insulin is reported in mIU/L.	Days 8 and 34
Secondary	Serum c-peptide	Serum c-peptide will be measured. Serum c-peptide is reported in ng/ml.	Days 8 and 34
Secondary	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
Secondary	Triglycerides in blood	Triglycerides will be measured. Triglycerides are reported as mmol/L.	Days 8 and 34