Measuring Daily Grain Intake Study

Healthy Volunteers Clinical Trial

Official title:

Measuring Daily Grain Intake Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04104581
• Other study ID #: HS64 Daily Grain
• Status: Completed
• Phase: N/A
• Start date: August 4, 2019
• Est. completion date: March 16, 2020

Study information

• Verified date: March 2020
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Control Refined Grain Diet
Subjects will be fed the average American diet except it will be free of whole grains
• Low Whole Grain Oat Diet
Subjects will be fed the average American diet with addition of a low level of whole grain oats
• High Whole Grain Oat Diet
Subjects will be fed the average American diet with addition of a high level of whole grain oats
• Low Whole Grain Wheat Diet
Subjects will be fed the average American diet with addition of a low level of whole grain wheat
• High Whole Grain Wheat Diet
Subjects will be fed the average American diet with addition of a high level of whole grain wheat

Locations

Country	Name	City	State
United States	USDA-ARS Beltsville Human Nutrition Research Center	Beltsville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
USDA Beltsville Human Nutrition Research Center	National Institute of Food and Agriculture

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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
Secondary	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
Secondary	Blood Glucose	Fasting blood glucose will be measured in mg/dL	Day 1 and 15 of each of the 5 fifteen day diet periods
Secondary	Blood Insulin	Fasting blood insulin will be measured in uIU/mL	Day 1 and 15 of each of the 5 fifteen day diet periods
Secondary	Blood Triglycerides	Fasting blood triglycerides will be measured in mg/dL	Day 1 and 15 of each of the 5 fifteen day diet periods
Secondary	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