Scavenging of Reactive Carbonyl Species by Apple Polyphenols in Human

Pharmacokinetics Clinical Trial

Official title:

Scavenging of Endogenous Reactive Carbonyl Species by Apple Polyphenols in Healthy Human Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911050
• Other study ID #: 18-0089
• Status: Completed
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: December 21, 2018

Study information

• Verified date: April 2019
• Source: North Carolina Agriculture & Technical State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

A crossover design was used. Twelve healthy volunteers were recruited and asked to avoid the consumption of any apple products starting 1 week before intervention and continuing throughout the entire study for a total of 3 weeks.

On week 2, each of six participants received 600 g apple blends (seeds removal) in a single dose, and afterwards, urine and blood samples at different timepoints over 24 h, and fecal sample at different timepoints over 48 h were collected. Meanwhile, other six participants received breakfast (without any apple products) only, and urine and blood samples at different timepoints over 24 h, and fecal sample at different timepoints over 48 h were collected.

On the contrary, on week 3, six participants who received apple blends on week 2 received breakfast only, and six participants who were used as control on week 2 received apple blends. And urine and blood samples at different timepoints over 24 h, and fecal sample at different timepoints over 48 h for both groups were collected.

Samples will be analyzed by LC-MS/MS. Pharmacokinetics of conjugates will be investigated.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Human Health
• Pharmacokinetics
• Polyphenols

Intervention

Dietary Supplement:
• Apple consumption
Apple blends (600 g) One single dose
• Control group
Breakfast without any apple-related products

Locations

Country	Name	City	State
United States	North Carolina Agriculture and Technical State University	Kannapolis	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
North Carolina Agriculture & Technical State University

Country where clinical trial is conducted

United States, 

Outcome

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