Measuring Single-Serving Grain Intake

NCT ID: NCT03783637

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-13
• Study Completion Date: 2019-06-19

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Whole Grain Oat

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

Group Type: OTHER

Whole grain oats

Intervention Type: OTHER

A meal containing whole grain oats

Whole Grain Wheat

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

Group Type: OTHER

Whole grain wheat

Intervention Type: OTHER

A meal containing whole grain wheat

Interventions

Whole grain oats

A meal containing whole grain oats

Intervention Type: OTHER

Whole grain wheat

A meal containing whole grain wheat

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

USDA Beltsville Human Nutrition Research Center

FED

Sponsor Role: lead

Responsible Party

Janet Novotny

Research Physiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

USDA-ARS Beltsville Human Nutrition Research Center

Beltsville, Maryland, United States

Countries

United States

Other Identifiers

HS62 - Single Grain

Identifier Type: -

Identifier Source: org_study_id