Pharmacokinetics Clinical Trial
Official title:
Avenanthramide and Saponin Bioavailability in Oat Bran
Verified date | August 2020 |
Source | North Carolina Agriculture & Technical State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
North Carolina Agriculture & Technical State University |
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 |
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 |
NCT01636024 -
To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594
|
Phase 1 | |
Completed |
NCT01976078 -
Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents
|
N/A | |
Completed |
NCT01682408 -
Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability
|
Phase 1 | |
Completed |
NCT01208155 -
Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets
|
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 |
NCT01260025 -
Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor
|
Phase 1 | |
Completed |
NCT00983242 -
Drug-Drug Interaction Between Colchicine and Verapamil ER
|
Phase 1 | |
Completed |
NCT00856570 -
A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects
|
Phase 1 | |
Completed |
NCT00984009 -
A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice
|
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 |
NCT01276119 -
The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males
|
Phase 1 | |
Completed |
NCT00746499 -
Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.
|
Phase 1 |