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

NCT ID: NCT03118167

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-12-31

Brief Summary

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.

Detailed 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

Conditions

Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Tea polyphenols & Acrylamide

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

Group Type: EXPERIMENTAL

Tea polyphenols

Intervention Type: DIETARY_SUPPLEMENT

Tea polyphenols 0.05g, 0.1g, 0.2g (starches filled up to 0.35g), edible capsule

Acrylamide (Potato Chips)

Intervention Type: OTHER

Potato Chips bought from market, corresponding to acrylamide (12.6μg/kg b.w. )

AOB-w & Acrylamide

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

Group Type: EXPERIMENTAL

AOB-w

Intervention Type: DIETARY_SUPPLEMENT

Water-soluble antioxidant of bamboo leaves 0.35g, edible capsule

Acrylamide (Potato Chips)

Intervention Type: OTHER

Potato Chips bought from market, corresponding to acrylamide (12.6μg/kg b.w. )

Placebo & Acrylamide

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

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: OTHER

Edible starches 0.35g, edible capsule

Acrylamide (Potato Chips)

Intervention Type: OTHER

Potato Chips bought from market, corresponding to acrylamide (12.6μg/kg b.w. )

Interventions

Tea polyphenols

Tea polyphenols 0.05g, 0.1g, 0.2g (starches filled up to 0.35g), edible capsule

Intervention Type: DIETARY_SUPPLEMENT

AOB-w

Water-soluble antioxidant of bamboo leaves 0.35g, edible capsule

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Edible starches 0.35g, edible capsule

Intervention Type: OTHER

Acrylamide (Potato Chips)

Potato Chips bought from market, corresponding to acrylamide (12.6μg/kg b.w. )

Intervention Type: OTHER

Other Intervention Names

TP; Water-soluble antioxidant of bamboo leaves

Eligibility Criteria

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Yu Zhang

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

RCT-001-AA

Identifier Type: -

Identifier Source: org_study_id