Avenanthramide and Saponin Bioavailability in Oat Bran

Not Applicable

Completed

• Conditions: Pharmacokinetics; Human Health; Polyphenols
• Interventions: Dietary Supplement: Oat Bran Consumption

• Registration Number: NCT04335435
• Lead Sponsor: North Carolina Agriculture & Technical State University

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.

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 Timeline

• Study Start: 2016-01-15
• Primary Completion: 2016-01-21
• Study Completion: 2016-01-21
• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-06
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oat Bran Consumption	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.

Primary Outcome Measures

Name	Time	Method
Bioavailability of Avenanthramides and Saponins in Urine	32-48 hours post-dose	Liquid chromatography-tandem mass spectrometry will be utilized to assess the bioavailability of avenanthramides and saponins in urine.