InterventionNCT03118167
Intervention Effect of TP and AOB-w on Acrylamide Exposure in Chinese Adolescents
A study testing Tea polyphenols, AOB-w and Acrylamide (Potato Chips) in people with Intervention, run by Zhejiang University.
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. Read more about this study
- Who is it for?
- Ages 17 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Intervention
- What is being tested?
- Tea polyphenols, AOB-w and Acrylamide (Potato Chips)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subject has no smoking or drinking hobby
Who cannot join
- Having any drugs within 7days
- Smoking or drinking
- Pregnant, trying to become pregnant or breast feeding
- Allergic frying foods
About this study
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
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.
Read the 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
- Intervention
- Being tested
- Tea polyphenols, AOB-w, Placebo, Acrylamide (Potato Chips)
- Keywords
- Acrylamide, Tea polyphenols, Water-soluble antioxidant of bamboo leaves
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tea polyphenolsDietary supplement
Also called TP
Tea polyphenols 0.05g, 0.1g, 0.2g (starches filled up to 0.35g), edible capsule
AOB-wDietary supplement
Also called Water-soluble antioxidant of bamboo leaves
Water-soluble antioxidant of bamboo leaves 0.35g, edible capsule
PlaceboOther
Edible starches 0.35g, edible capsule
Acrylamide (Potato Chips)Other
Potato Chips bought from market, corresponding to acrylamide (12.6μg/kg b.w. )
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Placebo; Other: Acrylamide (Potato Chips) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, 3 and 10 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study startMay 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InterventionStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Zhang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118167
- Sponsor's protocol ID
- RCT-001-AA
- Status last verified
- May 2017
- First submitted
- 24 Nov 2016
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03118167
- Acronym / sponsor ID
- RCT-001-AA
- Conditions
- Intervention
- Keywords
- Acrylamide, Tea polyphenols, Water-soluble antioxidant of bamboo leaves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tea polyphenols & Acrylamide | Experimental | Dietary Supplement: Tea polyphenols, Other: Acrylamide (Potato Chips)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 | Dietary Supplement: AOB-w, Other: Acrylamide (Potato Chips)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 | Other: Placebo, Other: Acrylamide (Potato Chips)Placebo (Starches) 0.35g capsule by mouth, Acrylamide (Potato Chips) 12.6μg/kg b.w. by mouth, for one single oral dose |
Who may qualify
- Ages
- 17 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Subject has no smoking or drinking hobby
Key exclusion criteria (4 listed)
- Having any drugs within 7days
- Smoking or drinking
- Pregnant, trying to become pregnant or breast feeding
- Allergic frying foods
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tea polyphenolsAlso: TPTea polyphenols 0.05g, 0.1g, 0.2g (starches filled up to 0.35g), edible capsule | Dietary supplement | Tea polyphenols & Acrylamide |
| AOB-wAlso: Water-soluble antioxidant of bamboo leavesWater-soluble antioxidant of bamboo leaves 0.35g, edible capsule | Dietary supplement | AOB-w & Acrylamide |
| PlaceboEdible starches 0.35g, edible capsule | Other | Placebo & Acrylamide |
| Acrylamide (Potato Chips)Potato Chips bought from market, corresponding to acrylamide (12.6μg/kg b.w. ) | Other | AOB-w & Acrylamide, Placebo & Acrylamide, Tea polyphenols & Acrylamide |
Primary outcome
Change of four urinary biomarkers of acrylamide
Time frame: up to 48 hours
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.
Change of two hemoglobin adducts of acrylamide
Time frame: baseline, 3 and 10 days
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.
3 secondary outcomes
Area under the concentration versus time curve (AUC) Of acrylamide urinary biomarkers
Time frame: baseline, 2, 4, 6, 8, 10, 14, 24, 36 and 48 hours
Maximum Concentration (Cmax) of Acrylamide Urinary Biomarkers
Time frame: 48 hours
Time to Peak Concentration (tmax) of Acrylamide Urinary Biomarkers
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Tea polyphenols, AOB-w and Acrylamide (Potato Chips) in people with Intervention, run by Zhejiang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of four urinary biomarkers of acrylamide (time frame: up to 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.