Scavenging of Reactive Carbonyl Species by Apple Polyphenols in Human

North Carolina Agriculture & Technical State University

Status: Completed

Conditions: Human Health; Pharmacokinetics; Polyphenols

Treatments: Dietary Supplement: Control group; Dietary Supplement: Apple consumption

Study type: Interventional

Funder types: Other

Identifiers

NCT03911050

18-0089

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

Apple consumption

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Apple consumption

Control group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Control group