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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03118167

Enrollment

110

Registered

2017-04-18

Start date

2014-05-31

Completion date

2014-12-31

Last updated

2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intervention

Keywords

Acrylamide, Tea polyphenols, Water-soluble antioxidant of bamboo leaves

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

Interventions

DIETARY_SUPPLEMENTTea polyphenols

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

DIETARY_SUPPLEMENTAOB-w

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

OTHERPlacebo

Edible starches 0.35g, edible capsule

OTHERAcrylamide (Potato Chips)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

17 Years to 29 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026