Scavenging of Reactive Carbonyl Species by Apple Polyphenols in Human
NCT ID: NCT03911050
Last Updated: 2019-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2018-11-26
2018-12-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Apple consumption
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.
Apple consumption
Apple blends (600 g) One single dose
Control group
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.
Control group
Breakfast without any apple-related products
Interventions
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Apple consumption
Apple blends (600 g) One single dose
Control group
Breakfast without any apple-related products
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
Yes
Sponsors
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North Carolina Agriculture & Technical State University
OTHER
Responsible Party
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Shengmin Sang
Principal Investigator
Principal Investigators
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Shengmin Sang, PhD
Role: PRINCIPAL_INVESTIGATOR
North Carolina Agriculture & Technical State University
Locations
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North Carolina Agriculture and Technical State University
Kannapolis, North Carolina, United States
Countries
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Other Identifiers
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18-0089
Identifier Type: -
Identifier Source: org_study_id
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