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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
Apple blends (600 g) One single dose
Breakfast without any apple-related products
North Carolina Agriculture and Technical State University
Kannapolis, North Carolina, United States
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
Time frame: 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
Time frame: 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
Time frame: 0, 24, 48 hours post-dose
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
Time frame: 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
Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS in plasma
Time frame: 0, 0.5, 1, 1.5, 2, 4, 8, 24 hours post-dose
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