Scavenging of Reactive Carbonyl Species by Apple Polyphenols in Human

Sponsor

North Carolina Agriculture & Technical State University (Other)

Overall Status

Completed

CT.gov ID

NCT03911050

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

14.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Human Health Polyphenols Pharmacokinetics	Dietary Supplement: Apple consumption Dietary Supplement: Control group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 26, 2018

Actual Primary Completion Date :

Dec 14, 2018

Actual Study Completion Date :

Dec 21, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: Apple consumption Apple blends (600 g) One single dose
Placebo Comparator: 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.	Dietary Supplement: Control group Breakfast without any apple-related products

Arm

Intervention/Treatment

Experimental: 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.

Dietary Supplement: Apple consumption

Apple blends (600 g) One single dose

Placebo Comparator: 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.

Dietary Supplement: Control group

Breakfast without any apple-related products

Outcome Measures

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Carolina Agriculture and Technical State University	Kannapolis	North Carolina	United States	28081

Sponsors and Collaborators

North Carolina Agriculture & Technical State University

Investigators

Principal Investigator: Shengmin Sang, PhD, North Carolina Agriculture & Technical State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shengmin Sang, Principal Investigator, North Carolina Agriculture & Technical State University

ClinicalTrials.gov Identifier:

NCT03911050

Other Study ID Numbers:

18-0089

First Posted:

Apr 10, 2019

Last Update Posted:

Apr 10, 2019

Last Verified:

Apr 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shengmin Sang, Principal Investigator, North Carolina Agriculture & Technical State University

endogenous reactive carbonyl species

apple consumption

formation of carbonyl species adducts of apple polyphenols

pharmacokinetics of adducts in human

intervention

Study Results

No Results Posted as of Apr 10, 2019