NCT03911050

Scavenging of Reactive Carbonyl Species by Apple Polyphenols in Human

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: North Carolina Agriculture & Technical State University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Human Health
• Polyphenols
• Pharmacokinetics

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Apple consumption	Apple blends (600 g) One single dose
DIETARY_SUPPLEMENT	Control group	Breakfast without any apple-related products

Timeline

• Start date: 2018-11-26
• Primary completion: 2018-12-14
• Completion: 2018-12-21
• First posted: 2019-04-10
• Last updated: 2019-04-10

Locations

1 site across 1 country: United States