Measuring Daily Grain Intake Study

May 7, 2020 updated by: Janet Novotny, USDA Beltsville Human Nutrition Research Center
The primary objective of this study is to identify markers of daily whole grain oat and whole grain wheat intake in humans.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control
Volunteers will consume a diet in which all grain foods are made from refined grains.
Other: Control Refined Grain Diet
Subjects will be fed the average American diet except it will be free of whole grains
Experimental: Low Whole Grain Oat Diet
Volunteers will consume a diet with a low level of whole grain oat incorporated into some of the foods.
Other: Low Whole Grain Oat Diet
Subjects will be fed the average American diet with addition of a low level of whole grain oats
Experimental: High Whole Grain Oat Diet
Volunteers will consume a diet with a high level of whole grain oat incorporated into some of the foods.
Other: High Whole Grain Oat Diet
Subjects will be fed the average American diet with addition of a high level of whole grain oats
Experimental: Low Whole Grain Wheat Diet
Volunteers will consume a diet with a low level of whole grain wheat incorporated into some of the foods.
Other: Low Whole Grain Wheat Diet
Subjects will be fed the average American diet with addition of a low level of whole grain wheat
Experimental: High Whole Grain Wheat Diet
Volunteers will consume a diet with a high level of whole grain wheat incorporated into some of the foods.
Other: High Whole Grain Wheat Diet
Subjects will be fed the average American diet with addition of a high level of whole grain wheat

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 1 of Period 1 (period = 15 days)
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
Day 1 of Period 2 (period = 15 days)
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
Day 1 of Period 3 (period = 15 days)
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
Day 1 of Period 4 (period = 15 days)
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
Day 1 of Period 5 (period = 15 days)
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
Day 8 of Period 1 (period = 15 days)
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
Day 8 of Period 2 (period = 15 days)
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
Day 8 of Period 3 (period = 15 days)
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
Day 8 of Period 4 (period = 15 days)
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
Day 8 of Period 5 (period = 15 days)
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
Day 15 of Period 1 (period = 15 days)
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
Day 15 of Period 2 (period = 15 days)
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
Day 15 of Period 3 (period = 15 days)
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
Day 15 of Period 4 (period = 15 days)
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
Day 15 of Period 5 (period = 15 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Day 1, 8, and 15 of each of the 5 fifteen day diet periods
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
Day 1, 8, and 15 of each of the 5 fifteen day diet periods
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
Day 1 and 15 of each of the 5 fifteen day diet periods
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
Day 1 and 15 of each of the 5 fifteen day diet periods
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
Day 1 and 15 of each of the 5 fifteen day diet periods
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
Day 1 and 15 of each of the 5 fifteen day diet periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
USDA Beltsville Human Nutrition Research Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Agriculture (USDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 16, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS64 Daily Grain

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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