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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03911050
Other study ID # 18-0089
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 26, 2018
Est. completion date December 21, 2018

Study information

Verified date April 2019
Source North Carolina Agriculture & Technical State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 21, 2018
Est. primary completion date December 14, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Apple consumption
Apple blends (600 g) One single dose
Control group
Breakfast without any apple-related products

Locations

Country Name City State
United States North Carolina Agriculture and Technical State University Kannapolis North Carolina

Sponsors (1)

Lead Sponsor Collaborator
North Carolina Agriculture & Technical State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Change in urinary levels of RCS over 24 hours after one single dose of apple consumption Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS in urine 0-2, 2-4, 4-6, 6-9, 9-12, 12-24 hours post-dose
Secondary Change in plasma levels of RCS over 24 hours after one single dose of apple consumption Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS in plasma 0, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose
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