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

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ClinicalTrials.gov Identifier: NCT03118167
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Yu Zhang, Zhejiang University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intervention Dietary Supplement: Tea polyphenols Dietary Supplement: AOB-w Other: Placebo Other: Acrylamide (Potato Chips) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official 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
Study Start Date : May 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arms and Interventions
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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 Name: 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
 Dietary Supplement: AOB-w
Water-soluble antioxidant of bamboo leaves 0.35g, edible capsule
Other Name: Water-soluble antioxidant of bamboo leaves

Other: Acrylamide (Potato Chips)
Potato Chips bought from market, corresponding to acrylamide (12.6μg/kg b.w. )
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: Placebo
Edible starches 0.35g, edible capsule

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Yu Zhang, Associate professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT03118167    
Other Study ID Numbers: RCT-001-AA
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yu Zhang, Zhejiang University:
Acrylamide
Tea polyphenols
Water-soluble antioxidant of bamboo leaves
Additional relevant MeSH terms:
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Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs