Measuring Daily Grain Intake Study

Beltsville Human Nutrition Research Center (BHNRC)

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: Low Whole Grain Wheat Diet; Other: Control Refined Grain Diet; Other: Low Whole Grain Oat Diet; Other: High Whole Grain Wheat Diet; Other: High Whole Grain Oat Diet

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04104581

HS64 Daily Grain

Details and patient eligibility

About

The primary objective of this study is to identify markers of daily 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 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.

Enrollment: 57 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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57 participants in 5 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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

Treatment:

Other: Control Refined Grain Diet

Low Whole Grain Oat Diet

Experimental group

Description:

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

Treatment:

Other: Low Whole Grain Oat Diet

High Whole Grain Oat Diet

Experimental group

Description:

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

Treatment:

Other: High Whole Grain Oat Diet

Low Whole Grain Wheat Diet

Experimental group

Description:

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

Treatment:

Other: Low Whole Grain Wheat Diet

High Whole Grain Wheat Diet

Experimental group

Description:

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

Treatment:

Other: High Whole Grain Wheat Diet