Intervention Effect of TP and AOB-w on Acrylamide Exposure in Chinese Adolescents

Zhejiang University

Status: Completed

Conditions: Intervention

Treatments: Dietary Supplement: Tea polyphenols; Dietary Supplement: AOB-w; Other: Placebo; Other: Acrylamide (Potato Chips)

Study type: Interventional

Funder types: Other

Identifiers

NCT03118167

RCT-001-AA

Details and patient eligibility

About

A double-blind randomized controlled trial (RCT) was conducted in current human study. This study aims to investigate the intervention effect of AOB-w on the short-term exposure and toxicokinetics of acrylamide, a dietary hazardous substance generated during heat processing, in Chinese adolescents.

Full description

In the morning of test day, participants were served with a meal of potato chips, corresponding to a single oral dose of 12.6 μg/kg b.w. exposure to acrylamide, and an edible capsule, which contains 350 mg AOB-w or the placebo with the same dose. Urine were collected within 48 hours thereafter. The diet was rigorously controlled within 24 hours prior to study till entire study finished. Four mercapturic acid metabolites have been investigated as urinary biomarkers for short-term internal exposure of acrylamide in human

Enrollment: 110 patients

Sex: All

Ages: 17 to 29 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject has no smoking or drinking hobby

Exclusion criteria

• Having any drugs within 7days
• Smoking or drinking
• Pregnant, trying to become pregnant or breast feeding
• Allergic frying foods

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 3 patient groups

Tea polyphenols & Acrylamide

Experimental group

Description:

TP 0.05g, 0.1g, 0.2g (starches filled, up to 0.35g) capsule by mouth, Acrylamide (Potato Chips) 12.6μg/kg b.w. by mouth, for one single oral dose

Treatment:

Other: Acrylamide (Potato Chips)

Dietary Supplement: Tea polyphenols

AOB-w & Acrylamide

Experimental group

Description:

AOB-w 0.35g capsule by mouth, Acrylamide (Potato Chips) 12.6μg/kg b.w. by mouth, for one single oral dose

Treatment:

Other: Acrylamide (Potato Chips)

Dietary Supplement: AOB-w

Placebo & Acrylamide

Active Comparator group

Description:

Placebo (Starches) 0.35g capsule by mouth, Acrylamide (Potato Chips) 12.6μg/kg b.w. by mouth, for one single oral dose

Treatment:

Other: Placebo

Other: Acrylamide (Potato Chips)