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

NCT03118167 | Completed

• 1 other identifier: RCT-001-AA
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intervention

Keywords

Acrylamide; Tea polyphenols; Water-soluble antioxidant of bamboo leaves

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Area under the concentration versus time curve (AUC) Of acrylamide urinary biomarkers

  baseline, 2, 4, 6, 8, 10, 14, 24, 36 and 48 hours

• Maximum Concentration (Cmax) of Acrylamide Urinary Biomarkers

  48 hours

• Time to Peak Concentration (tmax) of Acrylamide Urinary Biomarkers

  48 hours

Study Arms (3)

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

Dietary Supplement: Tea polyphenols; Other: Acrylamide (Potato Chips)

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

Dietary Supplement: AOB-w; Other: Acrylamide (Potato Chips)

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

Other: Placebo; Other: Acrylamide (Potato Chips)

Interventions

Tea polyphenols DIETARY_SUPPLEMENT

Tea polyphenols 0.05g, 0.1g, 0.2g (starches filled up to 0.35g), edible capsule

Also known as: TP

Tea polyphenols & Acrylamide

AOB-w DIETARY_SUPPLEMENT

Water-soluble antioxidant of bamboo leaves 0.35g, edible capsule

Also known as: Water-soluble antioxidant of bamboo leaves

AOB-w & Acrylamide

Placebo OTHER

Edible starches 0.35g, edible capsule

Placebo & Acrylamide

Acrylamide (Potato Chips) OTHER

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

AOB-w & Acrylamide; Placebo & Acrylamide; Tea polyphenols & Acrylamide

Eligibility Criteria

• Age: 17 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subject has no smoking or drinking hobby

You may not qualify if:

• Having any drugs within 7days
• Smoking or drinking
• Pregnant, trying to become pregnant or breast feeding
• Allergic frying foods

Sponsors & Collaborators

• Zhejiang University: lead

MeSH Terms

Interventions

Acrylamide

Intervention Hierarchy (Ancestors)

Acrylamides; Amides; Organic Chemicals; Acrylates; Acids, Acyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: April 18, 2017
• Study Start: May 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 17, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share