NCT04335435

Brief Summary

Avenanthramides and saponins are types of chemical compounds found naturally in oats. Avenanthramides have anti-oxidant properties, anti-atherosclerotic, anti-inflammation, and anti-proliferative effects on cancer cells in vitro. Oat saponins, or avenacosides, have the ability to bind cholesterol, and thus, the ability to lower blood cholesterol. Oat bran is a known source of these dietary compounds. This study aims to determine the bioavailability of these compounds to in the urine of participants after ingesting an oat bran cereal, both before, and after for multiple time points. Analytical chemistry will be used to determine the bioavailability of the oat compounds at each time point. This will help to establish a kinetic curve for the metabolism of these compounds.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2016

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2016

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
Last Updated

August 6, 2020

Status Verified

August 1, 2020

Enrollment Period

6 days

First QC Date

April 2, 2020

Last Update Submit

August 4, 2020

Conditions

Keywords

AvenanthramidesSaponinsbioavailabilitypolyphenolsoat branpharmacokinetics

Outcome Measures

Primary Outcomes (8)

  • Bioavailability of Avenanthramides and Saponins in Urine

    Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.

    0-2 hours post-dose

  • Bioavailability of Avenanthramides and Saponins in Urine

    Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.

    2-4 hours post-dose

  • Bioavailability of Avenanthramides and Saponins in Urine

    Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.

    4-6 hours post-dose

  • Bioavailability of Avenanthramides and Saponins in Urine

    Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.

    6-9 hours post-dose

  • Bioavailability of Avenanthramides and Saponins in Urine

    Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.

    9-12 hours post-dose

  • Bioavailability of Avenanthramides and Saponins in Urine

    Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.

    12-24 hours post-dose

  • Bioavailability of Avenanthramides and Saponins in Urine

    Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.

    24-32 hours post-dose

  • Bioavailability of Avenanthramides and Saponins in Urine

    Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.

    32-48 hours post-dose

Study Arms (1)

Oat Bran Consumption

EXPERIMENTAL

Each subject consumed 120 g of oat bran (by dry weight) in a single dose, and samples (urine and fecal) were collected at different time points following the administration of oat bran.

Dietary Supplement: Oat Bran Consumption

Interventions

Oat Bran ConsumptionDIETARY_SUPPLEMENT

Oat bran (120 g), single dose.

Also known as: Gut Microbiome and Oat metabolism Study
Oat Bran Consumption

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18.5-25
  • Have blood and urine biochemical markers in normal range
  • Have no known allergy to oat relate foods
  • Be not taking antibiotics for six months
  • Be not currently taking medication
  • Be nonsmoking
  • Have no alcoholic intoxication
  • Have no extensive exposure to industrial waste

You may not qualify if:

  • Individuals with gout
  • Individuals with heart disease
  • Individuals with peripheral vascular diseases
  • Individuals with degenerative liver
  • Cancer patients
  • Patients with diabetes
  • Individuals with GI disorders
  • Individuals with endocrine disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wang P, Zhang S, Yerke A, Ohland CL, Gharaibeh RZ, Fouladi F, Fodor AA, Jobin C, Sang S. Avenanthramide Metabotype from Whole-Grain Oat Intake is Influenced by Faecalibacterium prausnitzii in Healthy Adults. J Nutr. 2021 Jun 1;151(6):1426-1435. doi: 10.1093/jn/nxab006.

MeSH Terms

Interventions

Gastrointestinal Microbiome

Intervention Hierarchy (Ancestors)

MicrobiotaMicrobiological PhenomenaBiotaBiodiversityEcosystemEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Officials

  • Shengmin Sang, PhD

    North Carolina Agriculture and Technical State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 2, 2020

First Posted

April 6, 2020

Study Start

January 15, 2016

Primary Completion

January 21, 2016

Study Completion

January 21, 2016

Last Updated

August 6, 2020

Record last verified: 2020-08