CClinicalTrials.gg
CompletedNCT04335435Updated Aug 6, 2020

Avenanthramide and Saponin Bioavailability in Oat Bran

An interventional study of Oat Bran Consumption in Human Health, Polyphenols and Pharmacokinetics, sponsored by North Carolina Agriculture & Technical State University. Completed. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-06.

Sponsored by North Carolina Agriculture & Technical State University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 4 years 2 months after the study started (first participant enrolled Jan 2016, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the detailed description

Initially, the diet of the participants will be asked to restricted to avoid eating any polyphenols that might interfere with the employed analytical chemistry techniques. This period of diet restriction is the washout period. The list of foods to avoid are: oats, whole grains, fruits, vegetables, herbal supplements, ginger, coffee, tea, and chocolate.

After the washout period, a baseline urine and fecal sample will be collected from the participants, then a large portion of oat bran will be provided to the participants for consumption. The approximate portion size will be 100 g by dry weight. The participants will then provide urine samples during the designated time points. The time points for the urine collection are as follows:

  1. st sample, \~ 30 min to 1 hour prior to oat consumption
  2. nd sample: 0-2 hours after oat consumption
  3. rd sample: 2-4 hours after oat consumption
  4. th sample: 4-6 hours after oat consumption
  5. th sample: 6-9 hours after oat consumption
  6. th sample: 9-12 hours after oat consumption
  7. th sample: 12-24 hours after oat consumption
  8. th sample: 24-32 hours after oat consumption
  9. th sample: 48 hours after oat consumption These samples will be analyzed in using HPLC and LC/MS.
02

Conditions studied

  • Human Health
  • Polyphenols
  • Pharmacokinetics

Keywords

  • Avenanthramides
  • Saponins
  • bioavailability
  • polyphenols
  • oat bran
  • pharmacokinetics
03

In context

Lead sponsor

North Carolina Agriculture & Technical State University is the lead sponsor of 9 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Oat Bran Consumption

    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

  • Dietary supplementOat Bran Consumption

    Oat bran (120 g), single dose.

    Also known as: Gut Microbiome and Oat metabolism Study

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0-2 hours post-dose

  2. 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.

    Time frame: 2-4 hours post-dose

  3. 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.

    Time frame: 4-6 hours post-dose

  4. 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.

    Time frame: 6-9 hours post-dose

  5. 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.

    Time frame: 9-12 hours post-dose

  6. 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.

    Time frame: 12-24 hours post-dose

  7. 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.

    Time frame: 24-32 hours post-dose

  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.

    Time frame: 32-48 hours post-dose

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 33694368 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04335435
Lead sponsor
North Carolina Agriculture & Technical State University
Responsible party
Shengmin Sang (Principal Investigator, North Carolina Agriculture & Technical State University) — Principal investigator
First posted
Apr 6, 2020
Start date
Jan 15, 2016
Primary completion
Jan 21, 2016
Completion
Jan 21, 2016
Last update
Aug 6, 2020

Study contacts

Shengmin Sang, PhD
principal investigator · North Carolina Agriculture and Technical State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion