Avenanthramide and Saponin Bioavailability in Oat Bran

• Sponsor: North Carolina Agriculture & Technical State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04335435
• Collaborator: (none)
• Enrollment: 13
• Arm: 1
• Actual Duration (Days): 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Human Health; Polyphenols; Pharmacokinetics	Dietary Supplement: Oat Bran Consumption	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Avenanthramide and Saponin Bioavailability in Oat Bran
• Actual Study Start Date: Jan 15, 2016
• Actual Primary Completion Date: Jan 21, 2016
• Actual Study Completion Date: Jan 21, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Bioavailability of Avenanthramides and Saponins in Urine [0-2 hours post-dose]

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

2. Bioavailability of Avenanthramides and Saponins in Urine [2-4 hours post-dose]

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

3. Bioavailability of Avenanthramides and Saponins in Urine [4-6 hours post-dose]

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

4. Bioavailability of Avenanthramides and Saponins in Urine [6-9 hours post-dose]

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

5. Bioavailability of Avenanthramides and Saponins in Urine [9-12 hours post-dose]

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

6. Bioavailability of Avenanthramides and Saponins in Urine [12-24 hours post-dose]

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

7. Bioavailability of Avenanthramides and Saponins in Urine [24-32 hours post-dose]

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

8. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• North Carolina Agriculture & Technical State University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shengmin Sang, Principal Investigator, North Carolina Agriculture & Technical State University
• ClinicalTrials.gov Identifier: NCT04335435
• Other Study ID Numbers: 15-0179
• First Posted: Apr 6, 2020
• Last Update Posted: Aug 6, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shengmin Sang, Principal Investigator, North Carolina Agriculture & Technical State University: Avenanthramides; Saponins; bioavailability; polyphenols; oat bran; pharmacokinetics

Study Results

No Results Posted as of Aug 6, 2020