CClinicalTrials.gg
CompletedNCT03783637Updated Jul 5, 2019

Measuring Single-Serving Grain Intake

An interventional study of Whole grain oats and Whole grain wheat in Healthy Volunteers, sponsored by USDA Beltsville Human Nutrition Research Center. Completed at 1 site in United States. Open to participants aged 21 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by USDA Beltsville Human Nutrition Research Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
21 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

USDA Beltsville Human Nutrition Research Center is the lead sponsor of 29 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherWhole grain oats

    A meal containing whole grain oats

  • OtherWhole grain wheat

    A meal containing whole grain wheat

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 8

  2. 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.

    Time frame: Day 9

  3. 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.

    Time frame: Day 10

  4. 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.

    Time frame: Day 34

  5. 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.

    Time frame: Day 35

  6. 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.

    Time frame: Day 36

Secondary outcomes

  1. Blood glucose

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

    Time frame: Days 8 and 34

  2. Serum insulin

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

    Time frame: Days 8 and 34

  3. Serum c-peptide

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

    Time frame: Days 8 and 34

  4. Non-esterified fatty acids in blood

    Non-esterified fatty acids will be measured in blood. Non-esterified fatty acids are reported as mEQ/L.

    Time frame: Days 8 and 34

  5. Triglycerides in blood

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

    Time frame: Days 8 and 34

07

Study locations

1 site
  • USDA-ARS Beltsville Human Nutrition Research Center
    Beltsville, Maryland 20705, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03783637
Lead sponsor
USDA Beltsville Human Nutrition Research Center
Responsible party
Janet Novotny (Research Physiologist, USDA Beltsville Human Nutrition Research Center) — Principal investigator
First posted
Dec 21, 2018
Start date
May 13, 2019
Primary completion
Jun 19, 2019
Completion
Jun 19, 2019
Last update
Jul 5, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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