Clinical trial NCT04104581: Measuring Daily Grain Intake Study
Official title: Measuring Daily Grain Intake Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: United States Department of Agriculture (USDA)
First posted: 2019-09-26
Enrollment: 57
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Identification of unknown blood biomarkers of grain intake
timeFrame: Day 1 of Period 1 (period = 15 days)
measure: Identification of unknown blood biomarkers of grain intake
timeFrame: Day 1 of Period 2 (period = 15 days)
measure: Identification of unknown blood biomarkers of grain intake
timeFrame: Day 1 of Period 3 (period = 15 days)
measure: Identification of unknown blood biomarkers of grain intake
timeFrame: Day 1 of Period 4 (period = 15 days)
measure: Identification of unknown blood biomarkers of grain intake
timeFrame: Day 1 of Period 5 (period = 15 days)
measure: Identification of unknown blood biomarkers of grain intake
timeFrame: Day 8 of Period 1 (period = 15 days)
measure: Identification of unknown blood biomarkers of grain intake
timeFrame: Day 8 of Period 2 (period = 15 days)
measure: Identification of unknown blood biomarkers of grain intake
timeFrame: Day 8 of Period 3 (period = 15 days)
measure: Identification of unknown blood biomarkers of grain intake
timeFrame: Day 8 of Period 4 (period = 15 days)
measure: Identification of unknown blood biomarkers of grain intake
timeFrame: Day 8 of Period 5 (period = 15 days)
measure: Identification of unknown blood biomarkers of grain intake
timeFrame: Day 15 of Period 1 (period = 15 days)
measure: Identification of unknown blood biomarkers of grain intake
timeFrame: Day 15 of Period 2 (period = 15 days)
measure: Identification of unknown blood biomarkers of grain intake
timeFrame: Day 15 of Period 3 (period = 15 days)
measure: Identification of unknown blood biomarkers of grain intake
timeFrame: Day 15 of Period 4 (period = 15 days)
measure: Identification of unknown blood biomarkers of grain intake
timeFrame: Day 15 of Period 5 (period = 15 days)
Secondary outcomes:
measure: Identification of unknown urinary biomarkers of grain intake
timeFrame: Day 1, 8, and 15 of each of the 5 fifteen day diet periods
measure: Characterization of fecal microbiota
timeFrame: Day 1, 8, and 15 of each of the 5 fifteen day diet periods
measure: Blood Glucose
timeFrame: Day 1 and 15 of each of the 5 fifteen day diet periods
measure: Blood Insulin
timeFrame: Day 1 and 15 of each of the 5 fifteen day diet periods
measure: Blood Triglycerides
timeFrame: Day 1 and 15 of each of the 5 fifteen day diet periods
measure: Blood Non-Esterified Fatty Acids
timeFrame: Day 1 and 15 of each of the 5 fifteen day diet periods
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA-ARS Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
References: