Pharmacokinetics Clinical Trial
Official title:
Scavenging of Endogenous Reactive Carbonyl Species by Apple Polyphenols in Healthy Human Subjects
Verified date | April 2019 |
Source | North Carolina Agriculture & Technical State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an interventional study to investigate formation and pharmacokinetics of reactive carbonyl species adducts of apple polyphenols in human after a single dose of apple consumption.
Status | Completed |
Enrollment | 12 |
Est. completion date | December 21, 2018 |
Est. primary completion date | December 14, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - BMI between 17 and 30 - Have blood and urine biochemical markers in normal range - Have no known allergy to apples - Be not taking antibiotics for six months - Be not currently taking medication - Be nonsmoking - Have no alcoholic intoxication - Have no extensive exposure to industrial wastes - Be not frequent charred meat consumption Exclusion Criteria: - Individuals with gout - Individuals with heart diseases - Individuals with peripheral vascular diseases - Individuals with degenerative kidney - Individuals with degenerative liver - Cancer patients - Patients with diabetes - Individuals with GI disorders - Individuals with endocrine disorders |
Country | Name | City | State |
---|---|---|---|
United States | North Carolina Agriculture and Technical State University | Kannapolis | North Carolina |
Lead Sponsor | Collaborator |
---|---|
North Carolina Agriculture & Technical State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in urinary levels of reactive carbonyl species (RCS) adducts of apple polyphenols over 24 hours after one single dose of apple consumption | Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of apple polyphenols in urine | 0-2, 2-4, 4-6, 6-9, 9-12, 12-24 hours post-dose | |
Primary | Change in plasma levels of RCS adducts of apple polyphenols over 24 hours after one single dose of apple consumption | Liquid chromatography-tandem mass spectrometry will be used to assess RCS adducts of apple polyphenols in plasma | 0, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose | |
Primary | Change in levels of RCS adducts of apple polyphenols in feces over 48 hours after one single dose of apple consumption | Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of apple polyphenols in fecal samples | 0, 24, 48 hours post-dose | |
Secondary | Change in urinary levels of RCS over 24 hours after one single dose of apple consumption | Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS in urine | 0-2, 2-4, 4-6, 6-9, 9-12, 12-24 hours post-dose | |
Secondary | Change in plasma levels of RCS over 24 hours after one single dose of apple consumption | Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS in plasma | 0, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose |
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