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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Intervention

Intervention / Treatment
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* Dietary Supplement: Tea polyphenols
* Dietary Supplement: AOB-w
* Other: Placebo
* Other: Acrylamide (Potato Chips)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acrylamide, Tea polyphenols, Water-soluble antioxidant of bamboo leaves