Avenanthramide and Saponin Bioavailability in Oat Bran

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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics; Polyphenols; Human Health
• Intervention / Treatment: Dietary supplement: Oat Bran Consumption

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Oat bran (120 g), single dose.; Other Names: Gut Microbiome and Oat metabolism Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: North Carolina Agriculture & Technical State University
• Investigators: Principal Investigator: Shengmin Sang, PhD, North Carolina Agriculture and Technical State University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2016
• Primary Completion (Actual): January 21, 2016
• Study Completion (Actual): January 21, 2016

Study Registration Dates

• First Submitted: April 2, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: pharmacokinetics; bioavailability; polyphenols; Avenanthramides; Saponins; oat bran
• Other Study ID Numbers: 15-0179

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No