Healthy VolunteersNCT04104581
Measuring Daily Grain Intake Study
A study testing Low Whole Grain Oat Diet, High Whole Grain Oat Diet and Low Whole Grain Wheat Diet in people with Healthy Volunteers, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
Trial summary
The primary objective of this study is to identify markers of daily whole grain oat and whole grain wheat intake in humans. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Low Whole Grain Oat Diet, High Whole Grain Oat Diet and Low Whole Grain Wheat Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2019to 16 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 21 - 75 years
- non smokers
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA-ARS Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
The primary objective of this study is to identify markers of daily 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 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.
- Conditions
- Healthy Volunteers
- Being tested
- Control Refined Grain Diet, Low Whole Grain Oat Diet, High Whole Grain Oat Diet, Low Whole Grain Wheat Diet, High Whole Grain Wheat Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Refined Grain DietOther
Subjects will be fed the average American diet except it will be free of whole grains
Low Whole Grain Oat DietOther
Subjects will be fed the average American diet with addition of a low level of whole grain oats
High Whole Grain Oat DietOther
Subjects will be fed the average American diet with addition of a high level of whole grain oats
Low Whole Grain Wheat DietOther
Subjects will be fed the average American diet with addition of a low level of whole grain wheat
High Whole Grain Wheat DietOther
Subjects will be fed the average American diet with addition of a high level of whole grain wheat
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Volunteers will consume a diet in which all grain foods are made from refined grains. Receives: Other: Control Refined Grain Diet |
| Low Whole Grain Oat Diet | Experimental | Volunteers will consume a diet with a low level of whole grain oat incorporated into some of the foods. Receives: Other: Low Whole Grain Oat Diet |
| High Whole Grain Oat Diet | Experimental | Volunteers will consume a diet with a high level of whole grain oat incorporated into some of the foods. Receives: Other: High Whole Grain Oat Diet |
| Low Whole Grain Wheat Diet | Experimental | Volunteers will consume a diet with a low level of whole grain wheat incorporated into some of the foods. Receives: Other: Low Whole Grain Wheat Diet |
| High Whole Grain Wheat Diet | Experimental | Volunteers will consume a diet with a high level of whole grain wheat incorporated into some of the foods. Receives: Other: High Whole Grain Wheat Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of unknown blood biomarkers of grain intake
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
Measured: Day 1 of Period 1 (period = 15 days)
Identification of unknown blood biomarkers of grain intake
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
Measured: Day 1 of Period 2 (period = 15 days)
Identification of unknown blood biomarkers of grain intake
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
Measured: Day 1 of Period 3 (period = 15 days)
Identification of unknown blood biomarkers of grain intake
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
Measured: Day 1 of Period 4 (period = 15 days)
Identification of unknown blood biomarkers of grain intake
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
Measured: Day 1 of Period 5 (period = 15 days)
Identification of unknown blood biomarkers of grain intake
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
Measured: Day 8 of Period 1 (period = 15 days)
Identification of unknown blood biomarkers of grain intake
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
Measured: Day 8 of Period 2 (period = 15 days)
Identification of unknown blood biomarkers of grain intake
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
Measured: Day 8 of Period 3 (period = 15 days)
Identification of unknown blood biomarkers of grain intake
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
Measured: Day 8 of Period 4 (period = 15 days)
Identification of unknown blood biomarkers of grain intake
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
Measured: Day 8 of Period 5 (period = 15 days)
Identification of unknown blood biomarkers of grain intake
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
Measured: Day 15 of Period 1 (period = 15 days)
Identification of unknown blood biomarkers of grain intake
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
Measured: Day 15 of Period 2 (period = 15 days)
Identification of unknown blood biomarkers of grain intake
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
Measured: Day 15 of Period 3 (period = 15 days)
Identification of unknown blood biomarkers of grain intake
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
Measured: Day 15 of Period 4 (period = 15 days)
Identification of unknown blood biomarkers of grain intake
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
Measured: Day 15 of Period 5 (period = 15 days)
Secondary outcomes (6)
Identification of unknown urinary biomarkers of grain intake
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
Measured: Day 1, 8, and 15 of each of the 5 fifteen day diet periods
Characterization of fecal microbiota
Fecal samples will be analyzed for microbiota
Measured: Day 1, 8, and 15 of each of the 5 fifteen day diet periods
Blood Glucose
Fasting blood glucose will be measured in mg/dL
Measured: Day 1 and 15 of each of the 5 fifteen day diet periods
Blood Insulin
Fasting blood insulin will be measured in uIU/mL
Measured: Day 1 and 15 of each of the 5 fifteen day diet periods
Blood Triglycerides
Fasting blood triglycerides will be measured in mg/dL
Measured: Day 1 and 15 of each of the 5 fifteen day diet periods
Blood Non-Esterified Fatty Acids
Fasting blood non esterified fatty acids will be measured in mEQ/L
Measured: Day 1 and 15 of each of the 5 fifteen day diet periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start4 Aug 2019
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Beltsville Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Janet Novotny, USDA Beltsville Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104581
- Sponsor's protocol ID
- HS64 Daily Grain
- Status last verified
- Mar 2020
- First submitted
- 28 Aug 2019
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Y, Novotny JA, Baer D, Hu Y, Sun Q, Zhang S, Sang S. Betainized metabolites as biomarkers of whole grain wheat, not oat: insights from controlled crossover pharmacokinetic and daily feeding studies. Am J Clin Nutr. 2026 Feb;123(2):101139. doi: 10.1016/j.ajcnut.2025.101139. Epub 2025 Dec 19.
PubMed 41423132
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Daily Grain Intake Study
- ClinicalTrials.gov ID
- NCT04104581
- Acronym / sponsor ID
- HS64 Daily Grain
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- USDA Beltsville Human Nutrition Research CenterUS federal agency
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 4 Aug 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to identify markers of daily whole grain oat and whole grain wheat intake in humans.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Control Refined Grain DietVolunteers will consume a diet in which all grain foods are made from refined grains. |
| Low Whole Grain Oat Diet | Experimental | Other: Low Whole Grain Oat DietVolunteers will consume a diet with a low level of whole grain oat incorporated into some of the foods. |
| High Whole Grain Oat Diet | Experimental | Other: High Whole Grain Oat DietVolunteers will consume a diet with a high level of whole grain oat incorporated into some of the foods. |
| Low Whole Grain Wheat Diet | Experimental | Other: Low Whole Grain Wheat DietVolunteers will consume a diet with a low level of whole grain wheat incorporated into some of the foods. |
| High Whole Grain Wheat Diet | Experimental | Other: High Whole Grain Wheat DietVolunteers will consume a diet with a high level of whole grain wheat incorporated into some of the foods. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 21 - 75 years
- non smokers
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control Refined Grain DietSubjects will be fed the average American diet except it will be free of whole grains | Other | Control |
| Low Whole Grain Oat DietSubjects will be fed the average American diet with addition of a low level of whole grain oats | Other | Low Whole Grain Oat Diet |
| High Whole Grain Oat DietSubjects will be fed the average American diet with addition of a high level of whole grain oats | Other | High Whole Grain Oat Diet |
| Low Whole Grain Wheat DietSubjects will be fed the average American diet with addition of a low level of whole grain wheat | Other | Low Whole Grain Wheat Diet |
| High Whole Grain Wheat DietSubjects will be fed the average American diet with addition of a high level of whole grain wheat | Other | High Whole Grain Wheat Diet |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
6 secondary outcomes
Identification of unknown urinary biomarkers of grain intake
Time frame: 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
Blood Glucose
Time frame: 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
Blood Triglycerides
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Derived from this study: PubMed 41423132Li Y, Novotny JA, Baer D, Hu Y, Sun Q, Zhang S, Sang S. Betainized metabolites as biomarkers of whole grain wheat, not oat: insights from controlled crossover pharmacokinetic and daily feeding studies. Am J Clin Nutr. 2026 Feb;123(2):101139. doi: 10.1016/j.ajcnut.2025.101139. Epub 2025 Dec 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Whole Grain Oat Diet, High Whole Grain Oat Diet and Low Whole Grain Wheat Diet in people with Healthy Volunteers, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of unknown blood biomarkers of grain intake (time frame: Day 1 of Period 1 (period = 15 days)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04104581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.