Clinical trial NCT03911050: Scavenging of Reactive Carbonyl Species by Apple Polyphenols in Human
Official title: Scavenging of Endogenous Reactive Carbonyl Species by Apple Polyphenols in Healthy Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Health
Polyphenols
Pharmacokinetics
Keywords: endogenous reactive carbonyl species
apple consumption
formation of carbonyl species adducts of apple polyphenols
pharmacokinetics of adducts in human
intervention
Lead sponsor: North Carolina Agriculture & Technical State University
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in urinary levels of reactive carbonyl species (RCS) adducts of apple polyphenols over 24 hours after one single dose of apple consumption
timeFrame: 0-2, 2-4, 4-6, 6-9, 9-12, 12-24 hours post-dose
measure: Change in plasma levels of RCS adducts of apple polyphenols over 24 hours after one single dose of apple consumption
timeFrame: 0, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose
measure: Change in levels of RCS adducts of apple polyphenols in feces over 48 hours after one single dose of apple consumption
timeFrame: 0, 24, 48 hours post-dose
Secondary outcomes:
measure: Change in urinary levels of RCS over 24 hours after one single dose of apple consumption
timeFrame: 0-2, 2-4, 4-6, 6-9, 9-12, 12-24 hours post-dose
measure: Change in plasma levels of RCS over 24 hours after one single dose of apple consumption
timeFrame: 0, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: North Carolina Agriculture and Technical State University
state: North Carolina
Study officials:
affiliation: North Carolina Agriculture & Technical State University
name: Shengmin Sang, PhD
role: PRINCIPAL_INVESTIGATOR
References: