Measuring Daily Grain Intake Study

NCT04104581 | Completed

• 1 other identifier: HS64 Daily Grain
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (6)

• Identification of unknown urinary biomarkers of grain intake

  Day 1, 8, and 15 of each of the 5 fifteen day diet periods

• Characterization of fecal microbiota

  Day 1, 8, and 15 of each of the 5 fifteen day diet periods

• Blood Glucose

  Day 1 and 15 of each of the 5 fifteen day diet periods

• Blood Insulin

  Day 1 and 15 of each of the 5 fifteen day diet periods

• Blood Triglycerides

  Day 1 and 15 of each of the 5 fifteen day diet periods

Study Arms (5)

Control

PLACEBO COMPARATOR

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

Other: Control Refined Grain Diet

Low Whole Grain Oat Diet

EXPERIMENTAL

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

High Whole Grain Oat Diet

EXPERIMENTAL

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

Low Whole Grain Wheat Diet

EXPERIMENTAL

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

High Whole Grain Wheat Diet

EXPERIMENTAL

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

Interventions

Control Refined Grain Diet OTHER

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

Control

Low Whole Grain Oat Diet OTHER

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

Low Whole Grain Oat Diet

High Whole Grain Oat Diet OTHER

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

High Whole Grain Oat Diet

Low Whole Grain Wheat Diet OTHER

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

Low Whole Grain Wheat Diet

High Whole Grain Wheat Diet OTHER

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

High Whole Grain Wheat Diet

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 21 - 75 years
• non smokers

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• USDA Beltsville Human Nutrition Research Center: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

USDA-ARS Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Related Publications (1)

• Li Y, Novotny JA, Baer D, Hu Y, Sun Q, Zhang S, Sang S. Betainized metabolites as biomarkers of whole grain wheat, not oat: insights from controlled crossover pharmacokinetic and daily feeding studies. Am J Clin Nutr. 2025 Dec 19:101139. doi: 10.1016/j.ajcnut.2025.101139. Online ahead of print.

  PMID: 41423132 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Physiologist

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 26, 2019
• Study Start: August 4, 2019
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: May 11, 2020

Record last verified: 2020-03

Locations

US (1)