Status:
COMPLETED
Measuring Daily Grain Intake Study
Lead Sponsor:
USDA Beltsville Human Nutrition Research Center
Collaborating Sponsors:
United States Department of Agriculture (USDA)
Conditions:
Healthy Volunteers
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Aged 21 - 75 years
- non smokers
Exclusion
- 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
Key Trial Info
Start Date :
August 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2020
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04104581
Start Date
August 4 2019
End Date
March 16 2020
Last Update
May 11 2020
Active Locations (1)
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1
USDA-ARS Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705