Scavenging of Reactive Carbonyl Species by Apple Polyphenols in Human

April 9, 2019 updated by: Shengmin Sang, North Carolina Agriculture & Technical State University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Kannapolis, North Carolina, United States, 28081
        • North Carolina Agriculture and Technical State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in urinary levels of reactive carbonyl species (RCS) adducts of apple polyphenols over 24 hours after one single dose of apple consumption
Time Frame: 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
0-2, 2-4, 4-6, 6-9, 9-12, 12-24 hours post-dose
Change in plasma levels of RCS adducts of apple polyphenols over 24 hours after one single dose of apple consumption
Time Frame: 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
0, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose
Change in levels of RCS adducts of apple polyphenols in feces over 48 hours after one single dose of apple consumption
Time Frame: 0, 24, 48 hours post-dose
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in urinary levels of RCS over 24 hours after one single dose of apple consumption
Time Frame: 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
0-2, 2-4, 4-6, 6-9, 9-12, 12-24 hours post-dose
Change in plasma levels of RCS over 24 hours after one single dose of apple consumption
Time Frame: 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
0, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Carolina Agriculture & Technical State University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 26, 2018

Primary Completion (ACTUAL)

December 14, 2018

Study Completion (ACTUAL)

December 21, 2018

Study Registration Dates

First Submitted

April 8, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (ACTUAL)

April 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 9, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18-0089

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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