Measuring Daily Grain Intake Study

The primary objective of this study is to identify markers of daily whole grain oat and whole grain wheat intake in humans.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Control Refined Grain Diet; Other: Low Whole Grain Oat Diet; Other: High Whole Grain Oat Diet; Other: Low Whole Grain Wheat Diet; Other: High Whole Grain Wheat Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Beltsville, Maryland, United States, 20705
      • USDA-ARS Beltsville Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Volunteers will consume a diet in which all grain foods are made from refined grains.	Other: Control Refined Grain Diet; Subjects will be fed the average American diet except it will be free of whole grains
Experimental: Low Whole Grain Oat Diet; Volunteers will consume a diet with a low level of whole grain oat incorporated into some of the foods.	Other: Low Whole Grain Oat Diet; Subjects will be fed the average American diet with addition of a low level of whole grain oats
Experimental: High Whole Grain Oat Diet; Volunteers will consume a diet with a high level of whole grain oat incorporated into some of the foods.	Other: High Whole Grain Oat Diet; Subjects will be fed the average American diet with addition of a high level of whole grain oats
Experimental: Low Whole Grain Wheat Diet; Volunteers will consume a diet with a low level of whole grain wheat incorporated into some of the foods.	Other: Low Whole Grain Wheat Diet; Subjects will be fed the average American diet with addition of a low level of whole grain wheat
Experimental: High Whole Grain Wheat Diet; Volunteers will consume a diet with a high level of whole grain wheat incorporated into some of the foods.	Other: High Whole Grain Wheat Diet; Subjects will be fed the average American diet with addition of a high level of whole grain wheat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of unknown blood biomarkers of grain intake	Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined	Day 1 of Period 1 (period = 15 days)
Identification of unknown blood biomarkers of grain intake	Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined	Day 1 of Period 2 (period = 15 days)
Identification of unknown blood biomarkers of grain intake	Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined	Day 1 of Period 3 (period = 15 days)
Identification of unknown blood biomarkers of grain intake	Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined	Day 1 of Period 4 (period = 15 days)
Identification of unknown blood biomarkers of grain intake	Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined	Day 1 of Period 5 (period = 15 days)
Identification of unknown blood biomarkers of grain intake	Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined	Day 8 of Period 1 (period = 15 days)
Identification of unknown blood biomarkers of grain intake	Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined	Day 8 of Period 2 (period = 15 days)
Identification of unknown blood biomarkers of grain intake	Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined	Day 8 of Period 3 (period = 15 days)
Identification of unknown blood biomarkers of grain intake	Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined	Day 8 of Period 4 (period = 15 days)
Identification of unknown blood biomarkers of grain intake	Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined	Day 8 of Period 5 (period = 15 days)
Identification of unknown blood biomarkers of grain intake	Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined	Day 15 of Period 1 (period = 15 days)
Identification of unknown blood biomarkers of grain intake	Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined	Day 15 of Period 2 (period = 15 days)
Identification of unknown blood biomarkers of grain intake	Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined	Day 15 of Period 3 (period = 15 days)
Identification of unknown blood biomarkers of grain intake	Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined	Day 15 of Period 4 (period = 15 days)
Identification of unknown blood biomarkers of grain intake	Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined	Day 15 of Period 5 (period = 15 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of unknown urinary biomarkers of grain intake	Metabolomic analysis of urine samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined	Day 1, 8, and 15 of each of the 5 fifteen day diet periods
Characterization of fecal microbiota	Fecal samples will be analyzed for microbiota	Day 1, 8, and 15 of each of the 5 fifteen day diet periods
Blood Glucose	Fasting blood glucose will be measured in mg/dL	Day 1 and 15 of each of the 5 fifteen day diet periods
Blood Insulin	Fasting blood insulin will be measured in uIU/mL	Day 1 and 15 of each of the 5 fifteen day diet periods
Blood Triglycerides	Fasting blood triglycerides will be measured in mg/dL	Day 1 and 15 of each of the 5 fifteen day diet periods
Blood Non-Esterified Fatty Acids	Fasting blood non esterified fatty acids will be measured in mEQ/L	Day 1 and 15 of each of the 5 fifteen day diet periods

Collaborators and Investigators

• Sponsor: USDA Beltsville Human Nutrition Research Center
• Collaborators: United States Department of Agriculture (USDA)

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2019
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): March 16, 2020

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): May 11, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HS64 Daily Grain

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No