Measuring Single-Serving Grain Intake

Beltsville Human Nutrition Research Center (BHNRC)

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: Whole grain oats; Other: Whole grain wheat

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03783637

HS62 - Single Grain

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 2 patient groups

Whole Grain Oat

Other group

Description:

Volunteers will consume a breakfast meal containing whole grain oats after 7 days of a whole grain free diet.

Treatment:

Other: Whole grain oats

Whole Grain Wheat

Other group

Description:

Volunteers will consume a breakfast meal containing whole grain wheat after 7 days of a whole grain free diet.

Treatment:

Other: Whole grain wheat