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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tea polyphenols & Acrylamide | Experimental | 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 |
|
| AOB-w & Acrylamide | Experimental | AOB-w 0.35g capsule by mouth, Acrylamide (Potato Chips) 12.6μg/kg b.w. by mouth, for one single oral dose |
|
| Placebo & Acrylamide | Active Comparator | Placebo (Starches) 0.35g capsule by mouth, Acrylamide (Potato Chips) 12.6μg/kg b.w. by mouth, for one single oral dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tea polyphenols | Dietary Supplement | Tea polyphenols 0.05g, 0.1g, 0.2g (starches filled up to 0.35g), edible capsule |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D020106 | Acrylamide |
| ID | Term |
|---|---|
| D000178 | Acrylamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000179 | Acrylates |
| D000144 |
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| AOB-w | Dietary Supplement | Water-soluble antioxidant of bamboo leaves 0.35g, edible capsule |
|
|
| 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. ) |
|
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 |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |