Skip to main content
OpenTrials
Completed

NCT Number: NCT04104581

Measuring Daily Grain Intake Study

The primary objective of this study is to identify markers of daily whole grain oat and whole grain wheat intake in humans.

Completed

Looking for future studies?

Notify Me

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 repeated daily consumption 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

  • Aged 21 - 75 years
  • non smokers

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

Control Refined Grain Diet

Other

Subjects will be fed the average American diet except it will be free of whole grains

Low Whole Grain Oat Diet

Other

Subjects will be fed the average American diet with addition of a low level of whole grain oats

High Whole Grain Oat Diet

Other

Subjects will be fed the average American diet with addition of a high level of whole grain oats

Low Whole Grain Wheat Diet

Other

Subjects will be fed the average American diet with addition of a low level of whole grain wheat

High Whole Grain Wheat Diet

Other

Subjects will be fed the average American diet with addition of a high level of whole grain wheat

Primary outcomes

  1. Identification of unknown blood biomarkers of grain intake

    Time frame: Day 1 of Period 1 (period = 15 days)

    Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined

  2. Identification of unknown blood biomarkers of grain intake

    Time frame: Day 1 of Period 2 (period = 15 days)

    Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined

  3. Identification of unknown blood biomarkers of grain intake

    Time frame: Day 1 of Period 3 (period = 15 days)

    Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined

  4. Identification of unknown blood biomarkers of grain intake

    Time frame: Day 1 of Period 4 (period = 15 days)

    Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined

  5. Identification of unknown blood biomarkers of grain intake

    Time frame: Day 1 of Period 5 (period = 15 days)

    Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined

  6. Identification of unknown blood biomarkers of grain intake

    Time frame: Day 8 of Period 1 (period = 15 days)

    Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined

  7. Identification of unknown blood biomarkers of grain intake

    Time frame: Day 8 of Period 2 (period = 15 days)

    Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined

  8. Identification of unknown blood biomarkers of grain intake

    Time frame: Day 8 of Period 3 (period = 15 days)

    Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined

  9. Identification of unknown blood biomarkers of grain intake

    Time frame: Day 8 of Period 4 (period = 15 days)

    Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined

  10. Identification of unknown blood biomarkers of grain intake

    Time frame: Day 8 of Period 5 (period = 15 days)

    Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined

  11. Identification of unknown blood biomarkers of grain intake

    Time frame: Day 15 of Period 1 (period = 15 days)

    Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined

  12. Identification of unknown blood biomarkers of grain intake

    Time frame: Day 15 of Period 2 (period = 15 days)

    Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined

  13. Identification of unknown blood biomarkers of grain intake

    Time frame: Day 15 of Period 3 (period = 15 days)

    Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined

  14. Identification of unknown blood biomarkers of grain intake

    Time frame: Day 15 of Period 4 (period = 15 days)

    Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined

  15. Identification of unknown blood biomarkers of grain intake

    Time frame: Day 15 of Period 5 (period = 15 days)

    Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined

Secondary outcomes

  1. Identification of unknown urinary biomarkers of grain intake

    Time frame: Day 1, 8, and 15 of each of the 5 fifteen day diet periods

    Metabolomic analysis of urine samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined

  2. Characterization of fecal microbiota

    Time frame: Day 1, 8, and 15 of each of the 5 fifteen day diet periods

    Fecal samples will be analyzed for microbiota

  3. Blood Glucose

    Time frame: Day 1 and 15 of each of the 5 fifteen day diet periods

    Fasting blood glucose will be measured in mg/dL

  4. Blood Insulin

    Time frame: Day 1 and 15 of each of the 5 fifteen day diet periods

    Fasting blood insulin will be measured in uIU/mL

  5. Blood Triglycerides

    Time frame: Day 1 and 15 of each of the 5 fifteen day diet periods

    Fasting blood triglycerides will be measured in mg/dL

  6. Blood Non-Esterified Fatty Acids

    Time frame: Day 1 and 15 of each of the 5 fifteen day diet periods

    Fasting blood non esterified fatty acids will be measured in mEQ/L

Sponsors and collaborators

Lead sponsor

USDA Beltsville Human Nutrition Research Center

Fed

Collaborators

  • United States Department of Agriculture (USDA)

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2019
Registry last updated
May 11, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.