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Scavenging of Reactive Carbonyl Species by Apple Polyphenols in Human

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03911050
Enrollment
12
Registered
2019-04-10
Start date
2018-11-26
Completion date
2018-12-21
Last updated
2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Health, Pharmacokinetics, Polyphenols

Keywords

endogenous reactive carbonyl species, apple consumption, formation of carbonyl species adducts of apple polyphenols, pharmacokinetics of adducts in human, intervention

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.

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.

Interventions

DIETARY_SUPPLEMENTApple consumption

Apple blends (600 g) One single dose

DIETARY_SUPPLEMENTControl group

Breakfast without any apple-related products

Sponsors

North Carolina Agriculture & Technical State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORShengmin Sang, PhD

North Carolina Agriculture & Technical State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026