Measuring Daily Grain Intake Study

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: Low Whole Grain Oat Diet; Other: High Whole Grain Wheat Diet; Other: Control Refined Grain Diet; Other: High Whole Grain Oat Diet; Other: Low Whole Grain Wheat Diet

• Registration Number: NCT04104581
• Lead Sponsor: USDA Beltsville Human Nutrition Research Center

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.

Study Timeline

• Study Start: 2019-08-04
• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-26
• Status Verified: 2020-03
• Primary Completion: 2020-03-16
• Study Completion: 2020-03-16
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low Whole Grain Oat Diet	Low Whole Grain Oat Diet	Volunteers will consume a diet with a low level of whole grain oat incorporated into some of the foods.
High Whole Grain Wheat Diet	High Whole Grain Wheat Diet	Volunteers will consume a diet with a high level of whole grain wheat incorporated into some of the foods.
Control	Control Refined Grain Diet	Volunteers will consume a diet in which all grain foods are made from refined grains.
High Whole Grain Oat Diet	High Whole Grain Oat Diet	Volunteers will consume a diet with a high level of whole grain oat incorporated into some of the foods.
Low Whole Grain Wheat Diet	Low Whole Grain Wheat Diet	Volunteers will consume a diet with a low level of whole grain wheat incorporated into some of the foods.

Primary Outcome Measures

Name	Time	Method
Identification of unknown blood biomarkers of grain intake	Day 15 of Period 5 (period = 15 days)	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

Secondary Outcome Measures

Name	Time	Method
Blood Insulin	Day 1 and 15 of each of the 5 fifteen day diet periods	Fasting blood insulin will be measured in uIU/mL
Blood Triglycerides	Day 1 and 15 of each of the 5 fifteen day diet periods	Fasting blood triglycerides will be measured in mg/dL
Blood Non-Esterified Fatty Acids	Day 1 and 15 of each of the 5 fifteen day diet periods	Fasting blood non esterified fatty acids will be measured in mEQ/L
Blood Glucose	Day 1 and 15 of each of the 5 fifteen day diet periods	Fasting blood glucose will be measured in mg/dL
Identification of unknown urinary biomarkers of grain intake	Day 1, 8, and 15 of each of the 5 fifteen day diet periods	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
Characterization of fecal microbiota	Day 1, 8, and 15 of each of the 5 fifteen day diet periods	Fecal samples will be analyzed for microbiota

Trial Locations

Locations (1)

USDA-ARS Beltsville Human Nutrition Research Center; 🇺🇸 Beltsville, Maryland, United States