Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
Study NCT ID:
NCT04335435
Status:
COMPLETED
Last Update Posted:
2020-08-06
First Post:
2020-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Avenanthramide and Saponin Bioavailability in Oat Bran
Sponsor:
North Carolina Agriculture & Technical State University
Organization:
Study Overview
Official Title:
Avenanthramide and Saponin Bioavailability in Oat Bran
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: