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Completed

NCT Number: NCT03118167

Intervention Effect of TP and AOB-w on Acrylamide Exposure 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.

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Key information

Conditions

Intervention

Age range

17 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tea polyphenols

Dietary Supplement

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

Other names: TP

AOB-w

Dietary Supplement

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

Other names: Water-soluble antioxidant of bamboo leaves

Placebo

Other

Edible starches 0.35g, edible capsule

Acrylamide (Potato Chips)

Other

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

Primary outcomes

  1. Change of four urinary biomarkers of acrylamide

    Time frame: 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.

  2. Change of two hemoglobin adducts of acrylamide

    Time frame: 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.

Secondary outcomes

  1. Area under the concentration versus time curve (AUC) Of acrylamide urinary biomarkers

    Time frame: 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.

  2. Maximum Concentration (Cmax) of Acrylamide Urinary Biomarkers

    Time frame: 48 hours

    Maximum concentration of urinary biomarkers during the specified period, measured by curve fitting tools of Matlab Software.

  3. Time to Peak Concentration (tmax) of Acrylamide Urinary Biomarkers

    Time frame: 48 hours

    Time to Peak Concentration (tmax) of Acrylamide Urinary Biomarkers during the specified period, measured by curve fitting tools of Matlab Software.

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 18, 2017
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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