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

Intervention Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118167
• Other study ID #: RCT-001-AA
• Status: Completed
• Phase: N/A
• First received: November 24, 2016
• Last updated: May 16, 2017
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: May 2017
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Intervention

Intervention

Dietary Supplement:
• Tea polyphenols
Tea polyphenols 0.05g, 0.1g, 0.2g (starches filled up to 0.35g), edible capsule
• AOB-w
Water-soluble antioxidant of bamboo leaves 0.35g, edible capsule

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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