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

Not Applicable

Completed

• Conditions: Intervention
• Interventions: Dietary Supplement: Tea polyphenols; Dietary Supplement: AOB-w; Other: Placebo; Other: Acrylamide (Potato Chips)

• Registration Number: NCT03118167
• Lead Sponsor: Zhejiang University

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

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2016-11-24
• Study First Submitted QC: 2017-04-14
• Study First Posted: 2017-04-18
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo & Acrylamide	Acrylamide (Potato Chips)	Placebo (Starches) 0.35g capsule by mouth, Acrylamide (Potato Chips) 12.6μg/kg b.w. by mouth, for one single oral dose
AOB-w & Acrylamide	Acrylamide (Potato Chips)	AOB-w 0.35g capsule by mouth, Acrylamide (Potato Chips) 12.6μg/kg b.w. by mouth, for one single oral dose
Tea polyphenols & Acrylamide	Tea polyphenols	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
AOB-w & Acrylamide	AOB-w	AOB-w 0.35g capsule by mouth, Acrylamide (Potato Chips) 12.6μg/kg b.w. by mouth, for one single oral dose
Placebo & Acrylamide	Placebo	Placebo (Starches) 0.35g capsule by mouth, Acrylamide (Potato Chips) 12.6μg/kg b.w. by mouth, for one single oral dose
Tea polyphenols & Acrylamide	Acrylamide (Potato Chips)	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

Primary Outcome Measures

Name	Time	Method
Change of two hemoglobin adducts of acrylamide	baseline, 3 and 10 days	Blood samples were collected in 0, 3, 10days after the intake of potato chips meals. Two hemoglobin adducts (AAVal and GAVal) of acrylamide were detected by UHPLC-MS/MS.
Change of four urinary biomarkers of acrylamide	up to 48 hours	Urine was collected prior to the potato chips meal and 48 hours thereafter, up to 10 urine samples for each participants. Urinary biomarkers of acrylamide were detected by UHPLC-MS/MS.

Secondary Outcome Measures

Name	Time	Method
Time to Peak Concentration (tmax) of Acrylamide Urinary Biomarkers	48 hours	Time to Peak Concentration (tmax) of Acrylamide Urinary Biomarkers during the specified period, measured by curve fitting tools of Matlab Software.
Area under the concentration versus time curve (AUC) Of acrylamide urinary biomarkers	baseline, 2, 4, 6, 8, 10, 14, 24, 36 and 48 hours	Dynamic changes of biomarkers during the specified intervention period, following 10 urine samples in 48 hours thereafter.
Maximum Concentration (Cmax) of Acrylamide Urinary Biomarkers	48 hours	Maximum concentration of urinary biomarkers during the specified period, measured by curve fitting tools of Matlab Software.