Trials / Completed
CompletedNCT03118167
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- Zhejiang University · Academic / Other
- Sex
- All
- Age
- 17 Years – 29 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Tea polyphenols | Tea polyphenols 0.05g, 0.1g, 0.2g (starches filled up to 0.35g), edible capsule |
| DIETARY_SUPPLEMENT | AOB-w | Water-soluble antioxidant of bamboo leaves 0.35g, edible capsule |
| 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. ) |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2014-12-01
- Completion
- 2014-12-01
- First posted
- 2017-04-18
- Last updated
- 2017-05-17
Source: ClinicalTrials.gov record NCT03118167. Inclusion in this directory is not an endorsement.