Clinical trial NCT03783637: Measuring Single-Serving Grain Intake
Official title: Measuring Single-Serving Grain Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2018-12-21
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 21 to 75 years of age
* Voluntarily agree to participate and sign an informed consent form

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

Primary outcomes:
measure: Identification of unknown biomarkers of grain intake immediately after grain consumption
timeFrame: Day 8
measure: Identification of unknown biomarkers of grain intake a day after grain consumption
timeFrame: Day 9
measure: Identification of unknown biomarkers of grain intake 2 days after grain consumption
timeFrame: Day 10
measure: Identification of unknown biomarkers of grain intake immediately after grain consumption
timeFrame: Day 34
measure: Identification of unknown biomarkers of grain intake a day after grain consumption
timeFrame: Day 35
measure: Identification of unknown biomarkers of grain intake 2 days after grain consumption
timeFrame: Day 36
Secondary outcomes:
measure: Blood glucose
timeFrame: Days 8 and 34
measure: Serum insulin
timeFrame: Days 8 and 34
measure: Serum c-peptide
timeFrame: Days 8 and 34
measure: Non-esterified fatty acids in blood
timeFrame: Days 8 and 34
measure: Triglycerides in blood
timeFrame: Days 8 and 34
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA-ARS Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
References: