NCT03911050

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2018

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

18 days

First QC Date

April 8, 2019

Last Update Submit

April 9, 2019

Conditions

Human HealthPolyphenolsPharmacokinetics

Keywords

endogenous reactive carbonyl speciesapple consumptionformation of carbonyl species adducts of apple polyphenolspharmacokinetics of adducts in humanintervention

Outcome Measures

Primary Outcomes (3)

  • Change in urinary levels of reactive carbonyl species (RCS) adducts of apple polyphenols over 24 hours after one single dose of apple consumption

    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

    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

    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 Outcomes (2)

  • 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

  • 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

Study Arms (2)

Apple consumption

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Apple consumptionDIETARY_SUPPLEMENT

Apple blends (600 g) One single dose

Apple consumption
Control groupDIETARY_SUPPLEMENT

Breakfast without any apple-related products

Control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Carolina Agriculture and Technical State University

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Shengmin Sang, PhD

    North Carolina Agriculture & Technical State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 8, 2019

First Posted

April 10, 2019

Study Start

November 26, 2018

Primary Completion

December 14, 2018

Study Completion

December 21, 2018

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations

US(1)