Scavenging of Reactive Carbonyl Species by Apple Polyphenols in Human

NCT ID: NCT03911050

Last Updated: 2019-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-26

Study Completion Date

2018-12-21

Brief Summary

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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

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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

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Human Health Polyphenols Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Apple consumption

Intervention Type DIETARY_SUPPLEMENT

Apple blends (600 g) One single dose

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.

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type DIETARY_SUPPLEMENT

Breakfast without any apple-related products

Interventions

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Apple consumption

Apple blends (600 g) One single dose

Intervention Type DIETARY_SUPPLEMENT

Control group

Breakfast without any apple-related products

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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North Carolina Agriculture & Technical State University

OTHER

Sponsor Role lead

Responsible Party

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Shengmin Sang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shengmin Sang, PhD

Role: PRINCIPAL_INVESTIGATOR

North Carolina Agriculture & Technical State University

Locations

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North Carolina Agriculture and Technical State University

Kannapolis, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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18-0089

Identifier Type: -

Identifier Source: org_study_id

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