Avenanthramide & Saponin Bioavailability in Oat Bran

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04335435
Study type	Interventional
Source	North Carolina Agriculture & Technical State University
Contact
Status	Completed
Phase	N/A
Start date	January 15, 2016
Completion date	January 21, 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04092725` - Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects	Phase 1
Completed	`NCT04181008` - Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers	Early Phase 1
Active, not recruiting	`NCT03258151` - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
Completed	`NCT04406415` - Oral Nafamostat in Healthy Volunteers	Phase 1
Not yet recruiting	`NCT05421312` - Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip	Phase 4
Completed	`NCT02534753` - A Pharmacokinetics Study of Intravenous Ascorbic Acid	Phase 1
Completed	`NCT01682408` - Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability	Phase 1
Completed	`NCT01976078` - Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents	N/A
Completed	`NCT01636024` - To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594	Phase 1
Completed	`NCT01214941` - Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol	Phase 4
Completed	`NCT01415102` - A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.	Phase 1
Completed	`NCT01208155` - Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets	Phase 1
Completed	`NCT01260025` - Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor	Phase 1
Completed	`NCT00746499` - Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.	Phase 1
Completed	`NCT00856570` - A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects	Phase 1
Completed	`NCT01055964` - a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients	Phase 3
Completed	`NCT00730145` - A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis	Phase 1
Completed	`NCT00984009` - A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice	Phase 1
Completed	`NCT00983242` - Drug-Drug Interaction Between Colchicine and Verapamil ER	Phase 1
Completed	`NCT01276119` - The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Avenanthramide and Saponin Bioavailability in Oat Bran

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms