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

Intervention Effect of Tea Polyphenols (TP) and Water-Soluble Antioxidant Of Bamboo Leaves (AOB-w) on Short- and Long-term Internal Exposure of Acrylamide in Chinese Adolescents

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.

Study Overview

• Status: Completed
• Conditions: Intervention
• Intervention / Treatment: Dietary supplement: Tea polyphenols; Other: Acrylamide (Potato Chips); Dietary supplement: AOB-w; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 29 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: Tea polyphenols; Tea polyphenols 0.05g, 0.1g, 0.2g (starches filled up to 0.35g), edible capsule; Other Names: TP; Other: Acrylamide (Potato Chips); Potato Chips bought from market, corresponding to acrylamide (12.6μg/kg b.w. )
Experimental: 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	Other: Acrylamide (Potato Chips); Potato Chips bought from market, corresponding to acrylamide (12.6μg/kg b.w. ); Dietary supplement: AOB-w; Water-soluble antioxidant of bamboo leaves 0.35g, edible capsule; Other Names: Water-soluble antioxidant of bamboo leaves
Active Comparator: Placebo & Acrylamide; Placebo (Starches) 0.35g capsule by mouth, Acrylamide (Potato Chips) 12.6μg/kg b.w. by mouth, for one single oral dose	Other: Acrylamide (Potato Chips); Potato Chips bought from market, corresponding to acrylamide (12.6μg/kg b.w. ); Other: Placebo; Edible starches 0.35g, edible capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of four urinary biomarkers of acrylamide	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.	up to 48 hours
Change of two hemoglobin adducts of acrylamide	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.	baseline, 3 and 10 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhejiang University

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 24, 2016
• First Submitted That Met QC Criteria: April 14, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Acrylamide; Tea polyphenols; Water-soluble antioxidant of bamboo leaves
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants
• Other Study ID Numbers: RCT-001-AA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO