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NCT Number: NCT03911050

Scavenging of Reactive Carbonyl Species by Apple Polyphenols in Human

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.

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Key information

Conditions

Human Health Pharmacokinetics Polyphenols

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Carolina Agriculture and Technical State University

Kannapolis, North Carolina, 28081, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apple consumption

Dietary Supplement

Apple blends (600 g) One single dose

Control group

Dietary Supplement

Breakfast without any apple-related products

Primary outcomes

  1. Maximum Urinary Excretion Rates of Major Reactive Carbonyl Species (RCS) Adducts of Apple Polyphenols Over 24 Hours After One Single Dose of Apple Consumption

    Time frame: Urinary excretion rates (ERs) of ACR-PPs and MGO-PPs at different time intervals (0-2, 2-4, 4-6, 6-9, 9-12, and 12-24 h) after apple consumption were measured. The maximum ERs at 6 h post-dose for ACR-PPs and 9 h post-dose for MGO-PPs were presented.

    Urinary excretion rates of major reactive carbonyl species (RCS) conjugates were determined using LC-MS analysis. Urine samples were enzymatically hydrolyzed. Chromatographic separation of RCS-polyphenols (PPs) in human urine was performed on a Gemini column (50 mm × 2.0 mm; i.d. 3 μm) using a Dionex HPLC. Targeted conjugates were identified using an LTQ Velos Pro ion trap mass spectrometer equipped with an electrospray ionization (ESI) source operating in negative ion mode. Quantitation for RCS-PPs was carried out by using multiple reaction monitoring (MRM3) transitions (parent → product ion), and data were processed using Xcalibur Quan Browser (Version 4.2.47).

  2. Change in Plasma Levels of Major RCS Adducts of Apple Polyphenols Over 24 Hours After One Single Dose of Apple Consumption

    Time frame: Major RCS conjugates in plasma at different timepoints (0, 0.5, 1, 1.5, 2, 4, 8, and 24 h) after apple consumption were analyzed.

    Levels of RCS adducts of apple polyphenols in plasma will be determined by Liquid chromatography-tandem mass spectrometry analysis.

  3. Change in Levels of RCS Adducts of Apple Polyphenols in Feces Over 48 Hours After One Single Dose of Apple Consumption

    Time frame: Major RCS adducts of apple polyphenols at different time intervals (0, 0-24, and 24-48 h) after apple consumption were analyzed.

    Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of apple polyphenols in fecal samples

Secondary outcomes

  1. Average Urinary Excretion Rates of Major RCS (e.g. ACR and MGO) Over 24 Hours After One Single Dose of Apple Consumption

    Time frame: Urinary excretion rates (ERs) of major RCS (e.g. ACR and MGO) at different time intervals (0-2, 2-4, 4-6, 6-9, 9-12, and 12-24 h) post-dose were measured. Average urinary ERs of ACR and MGO within 24 h were presented.

    Average excretion rates of major RCS in urine were determined by Liquid chromatography-tandem mass spectrometry analysis. Urine samples were derivatized with DNPH solution. Chromatographic separation of RCS-DNPH adducts in samples was conducted on an Accucore C8 column. The thermo Q Exactive Plus Orbitrap mass spectrometer equipped with a heated-electrospray ionization (HESI) source was operated in a highly sensitive targeted-single ion monitoring (tSIM) mode, with positive ion polarity from 0 to 4.6 min and negative ion polarity from 4.6 to 13 min, for quantitative analysis.

  2. Average Plasma Levels of Major RCS (ACR and MGO) Over 24 Hours After One Single Dose of Apple Consumption

    Time frame: Plasma levels of major RCS (e.g. ACR and MGO) at different time points (0, 0.5, 1.0, 1.5, 2.0, 4.0, 8.0, and 24 h) post-dose were measured. Average plasma levels of ACR and MGO within 24 h were presented.

    Plasma levels of major RCS were determined by Liquid chromatography-tandem mass spectrometry analysis. Plasma samples were derivatized with DNPH solution. Chromatographic separation of RCS-DNPH adducts in samples was conducted on an Accucore C8 column. The thermo Q Exactive Plus Orbitrap mass spectrometer equipped with a heated-electrospray ionization (HESI) source was operated in a highly sensitive targeted-single ion monitoring (tSIM) mode, with positive ion polarity from 0 to 4.6 min and negative ion polarity from 4.6 to 13 min, for quantitative analysis.

Sponsors and collaborators

Lead sponsor

North Carolina Agriculture & Technical State University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 10, 2019
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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