Measuring Daily Grain Intake Study

NCT ID: NCT04104581

Last Updated: 2020-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-04
• Study Completion Date: 2020-03-16

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.

Conditions

Healthy Volunteers

Study Design

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

Study Groups

Control

Volunteers will consume a diet in which all grain foods are made from refined grains.

Group Type: PLACEBO_COMPARATOR

Control Refined Grain Diet

Intervention Type: OTHER

Subjects will be fed the average American diet except it will be free of whole grains

Low Whole Grain Oat Diet

Volunteers will consume a diet with a low level of whole grain oat incorporated into some of the foods.

Group Type: EXPERIMENTAL

Low Whole Grain Oat Diet

Intervention Type: OTHER

Subjects will be fed the average American diet with addition of a low level of whole grain oats

High Whole Grain Oat Diet

Volunteers will consume a diet with a high level of whole grain oat incorporated into some of the foods.

Group Type: EXPERIMENTAL

High Whole Grain Oat Diet

Intervention Type: OTHER

Subjects will be fed the average American diet with addition of a high level of whole grain oats

Low Whole Grain Wheat Diet

Volunteers will consume a diet with a low level of whole grain wheat incorporated into some of the foods.

Group Type: EXPERIMENTAL

Low Whole Grain Wheat Diet

Intervention Type: OTHER

Subjects will be fed the average American diet with addition of a low level of whole grain wheat

High Whole Grain Wheat Diet

Volunteers will consume a diet with a high level of whole grain wheat incorporated into some of the foods.

Group Type: EXPERIMENTAL

High Whole Grain Wheat Diet

Intervention Type: OTHER

Subjects will be fed the average American diet with addition of a high level of whole grain wheat

Interventions

Control Refined Grain Diet

Subjects will be fed the average American diet except it will be free of whole grains

Intervention Type: OTHER

Low Whole Grain Oat Diet

Subjects will be fed the average American diet with addition of a low level of whole grain oats

Intervention Type: OTHER

High Whole Grain Oat Diet

Subjects will be fed the average American diet with addition of a high level of whole grain oats

Intervention Type: OTHER

Low Whole Grain Wheat Diet

Subjects will be fed the average American diet with addition of a low level of whole grain wheat

Intervention Type: OTHER

High Whole Grain Wheat Diet

Subjects will be fed the average American diet with addition of a high level of whole grain wheat

Intervention Type: OTHER

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

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

Sponsors

United States Department of Agriculture (USDA)

FED

Sponsor Role: collaborator

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

HS64 Daily Grain

Identifier Type: -

Identifier Source: org_study_id