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Completed

NCT Number: NCT03783637

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.

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Key information

Conditions

Healthy Volunteers

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA-ARS Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole grain oats

Other

A meal containing whole grain oats

Whole grain wheat

Other

A meal containing whole grain wheat

Primary outcomes

  1. Identification of unknown biomarkers of grain intake immediately after grain consumption

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Blood glucose

    Time frame: Days 8 and 34

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

  2. Serum insulin

    Time frame: Days 8 and 34

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

  3. Serum c-peptide

    Time frame: 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

    Time frame: 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

    Time frame: Days 8 and 34

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

Sponsors and collaborators

Lead sponsor

USDA Beltsville Human Nutrition Research Center

Fed

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2018
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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