Scavenging of Reactive Carbonyl Species by Apple Polyphenols in Human

Study Overview
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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.

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

Conditions
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Human Health, Polyphenols, Pharmacokinetics

Intervention / Treatment
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* Dietary Supplement: Apple consumption
* Dietary Supplement: Control group


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apple consumption<br>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. | Dietary Supplement: Apple consumption<br>* Apple blends (600 g) One single dose<br>|
| Placebo Comparator: Control group<br>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. | Dietary Supplement: Control group<br>* Breakfast without any apple-related products<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endogenous reactive carbonyl species, apple consumption, formation of carbonyl species adducts of apple polyphenols, pharmacokinetics of adducts in human, intervention