Avenanthramide and Saponin Bioavailability in Oat Bran

Pharmacokinetics Clinical Trial

Official title:

Avenanthramide and Saponin Bioavailability in Oat Bran

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04335435
• Other study ID #: 15-0179
• Status: Completed
• Phase: N/A
• Start date: January 15, 2016
• Est. completion date: January 21, 2016

Study information

• Verified date: August 2020
• Source: North Carolina Agriculture & Technical State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 21, 2016
• Est. primary completion date: January 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Human Health
• Pharmacokinetics
• Polyphenols

Intervention

Dietary Supplement:
• Oat Bran Consumption
Oat bran (120 g), single dose.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
North Carolina Agriculture & Technical State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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