Avenanthramide and Saponin Bioavailability in Oat Bran

NCT ID: NCT04335435

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-15
• Study Completion Date: 2016-01-21

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.

Conditions

Human Health; Polyphenols; Pharmacokinetics

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oat Bran Consumption

Intervention Type: DIETARY_SUPPLEMENT

Oat bran (120 g), single dose.

Interventions

Oat Bran Consumption

Oat bran (120 g), single dose.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Gut Microbiome and Oat metabolism Study

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

North Carolina Agriculture & Technical State University

OTHER

Sponsor Role: lead

Responsible Party

Shengmin Sang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shengmin Sang, PhD

Role: PRINCIPAL_INVESTIGATOR

North Carolina Agriculture and Technical State University

References

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.

Reference Type: DERIVED

PMID: 33694368 (View on PubMed)

Other Identifiers

15-0179

Identifier Type: -

Identifier Source: org_study_id