Scavenging of Reactive Carbonyl Species by Apple Polyphenols in Human

Not Applicable

Completed

• Conditions: Polyphenols; Pharmacokinetics; Human Health
• Interventions: Dietary Supplement: Apple consumption; Dietary Supplement: Control group

• Registration Number: NCT03911050
• Lead Sponsor: North Carolina Agriculture & Technical State University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-11-26
• Primary Completion: 2018-12-14
• Study Completion: 2018-12-21
• Status Verified: 2019-04
• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-09
• Last Update Submitted: 2019-04-09
• Study First Posted: 2019-04-10
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Apple consumption	Apple consumption	Each subject took apple blends 600 g (made from two apples with seed removal) in a single dose, and samples (urine and blood and feces) at different timepoints were collected following administration of apple blends.
Control group	Control group	Each subject took breakfast without any apple-related products in a single dose, and samples (urine and blood and feces) at different timepoints were collected following breakfast.

Primary Outcome Measures

Name	Time	Method
Change in plasma levels of RCS adducts of apple polyphenols over 24 hours after one single dose of apple consumption	0, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose	Liquid chromatography-tandem mass spectrometry will be used to assess RCS adducts of apple polyphenols in plasma
Change in levels of RCS adducts of apple polyphenols in feces over 48 hours after one single dose of apple consumption	0, 24, 48 hours post-dose	Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of apple polyphenols in fecal samples
Change in urinary levels of reactive carbonyl species (RCS) adducts of apple polyphenols over 24 hours after one single dose of apple consumption	0-2, 2-4, 4-6, 6-9, 9-12, 12-24 hours post-dose	Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of apple polyphenols in urine

Secondary Outcome Measures

Name	Time	Method
Change in urinary levels of RCS over 24 hours after one single dose of apple consumption	0-2, 2-4, 4-6, 6-9, 9-12, 12-24 hours post-dose	Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS in urine
Change in plasma levels of RCS over 24 hours after one single dose of apple consumption	0, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose	Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS in plasma

Trial Locations

Locations (1)

North Carolina Agriculture and Technical State University; 🇺🇸 Kannapolis, North Carolina, United States