Intestinal DysfunctionNCT06436989
Effect of Temperature Leaching Solution of Disposable Plastic Tableware on Intestinal Health of Adults
A study testing hot purified water in people with Intestinal Dysfunction and Inflammation, run by Xiang Zeng at 1 site in China.
Trial summary
Studies have shown that disposable plastic tableware will cause harm to human health after heat exposure, which is closely related to the rapid development of modern society and economy and the accelerated pace of life. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Dysfunction, Inflammation
- What is being tested?
- hot purified water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2024to 20 Dec 2024
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- .Healthy college students aged 18 to 35;
- .Subjects can receive the intervention in this study.
Who cannot join
- 1.Have been diagnosed with diabetes, ulcerative colitis, Crohn's disease, or an infectious disease;
- Chemotherapy, radiation or surgery 3-6 months prior to sampling;
- Abnormal bowel movements one week before sampling;
- I was menstruating at the time of sampling;
- In the past three months, the sample has taken probiotics and other related health products and dietary supplements.
Trial locations and contacts
1 site in 1 country.
About this study
Studies have shown that disposable plastic tableware will cause harm to human health after heat exposure, which is closely related to the rapid development of modern society and economy and the accelerated pace of life. Most of the existing studies focused on the characterization of micro-nano plastic particles and organic pollutants such as bisphenol A and polycyclic aromatic hydrocarbons produced after thermal exposure of disposable plastic tableware, but did not pay sufficient attention to the potential relationship with individual health effects. In addition; Sporadic animal tests and molecular tests have verified the health hazards of disposable plastic tableware leaching solution. Based on the previous research results, we believe that the leaching solution of disposable plastic tableware at high temperature environment will disturb the intestinal flora structure, affect the intestinal metabolic profile, and produce adverse health outcomes for human intestinal health. This study intends to recruit healthy school students as research objects, and collect urine and stool samples of test subjects, in order to explore the effects of high-temperature leaching solution of disposable plastic tableware on intestinal health of adults.
Read the detailed description
The method of single blind randomized controlled cross trial was adopted. A total of 80 healthy adults were recruited and divided into test group and control group according to the principle of randomization. During the trial period, the experimental group used a disposable plastic cup to drink a cup of hot water boiled in a hot kettle in the morning and in the evening (reduced to room temperature, about 300mL), while the control group also used a disposable plastic cup to drink room temperature water without heat exposure. The first phase lasted for 5 working weeks, and after a one-month washout period in the middle, the experimental group and the control group crossed. The second phase of the cross-over trial also lasted 5 workweeks. A total of four medical examinations were performed throughout the trial period, before and after the first and second trials. A check-up lasts half a day.
Health outcome indicators: height, weight, body composition analysis, saliva, blood pressure, blood, urine sample, stool sample indicators.
Urine, feces and blood samples were collected to detect the relevant indicators in order to explore the potential mechanism of the harm of heavy metals in the hot exposure leaching solution of disposable plastic tableware to human intestinal health.
- Conditions
- Intestinal Dysfunction, Inflammation
- Being tested
- hot purified water
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hot purified waterOther
Hot purified water,drink once a workday,almost 360mL.Buy from regular channels.
| Study group | Role | What they receive |
|---|---|---|
| hot water | Experimental | 300ml pure water cooled to room temperature in a kettle. Receives: Other: hot purified water |
| normal temperature water | Placebo comparator | 300 ml pure water without any treatment Receives: Other: hot purified water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity(FVC)
We plan to measure forced vital capacity (FVC) of lung function.
Measured: Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4weeks plants exposure in second stage
Blood Pressure(BP)
We plan to measure systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Measured: Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4weeks plants exposure in second stage.
Secondary outcomes (1)
Heart Rate Variability(HRV)
We plan to measure Heart Rate Variability (HRV).
Measured: Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4weeks plants exposure in second stage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start24 Mar 2024
- Primary completion13 Jun 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal DysfunctionStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiang Zeng
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Xiang Zeng, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436989
- Sponsor's protocol ID
- 20240306-1
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Temperature Leaching Solution of Disposable Plastic Tableware on Intestinal Health of Adults
- ClinicalTrials.gov ID
- NCT06436989
- Acronym / sponsor ID
- 20240306-1
- Conditions
- Intestinal Dysfunction, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xiang ZengOther government
- Study start
- 24 Mar 2024 (actual)
- Primary completion
- 13 Jun 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 31 May 2024 (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.
Studies have shown that disposable plastic tableware will cause harm to human health after heat exposure, which is closely related to the rapid development of modern society and economy and the accelerated pace of life. Most of the existing studies focused on the characterization of micro-nano plastic particles and organic pollutants such as bisphenol A and polycyclic aromatic hydrocarbons produced after thermal exposure of disposable plastic tableware, but did not pay sufficient attention to the potential relationship with individual health effects. In addition; Sporadic animal tests and molecular tests have verified the health hazards of disposable plastic tableware leaching solution. Based on the previous research results, we believe that the leaching solution of disposable plastic tableware at high temperature environment will disturb the intestinal flora structure, affect the intestinal metabolic profile, and produce adverse health outcomes for human intestinal health. This study intends to recruit healthy school students as research objects, and collect urine and stool samples of test subjects, in order to explore the effects of high-temperature leaching solution of disposable plastic tableware on intestinal health of adults.
Detailed description
The method of single blind randomized controlled cross trial was adopted. A total of 80 healthy adults were recruited and divided into test group and control group according to the principle of randomization. During the trial period, the experimental group used a disposable plastic cup to drink a cup of hot water boiled in a hot kettle in the morning and in the evening (reduced to room temperature, about 300mL), while the control group also used a disposable plastic cup to drink room temperature water without heat exposure. The first phase lasted for 5 working weeks, and after a one-month washout period in the middle, the experimental group and the control group crossed. The second phase of the cross-over trial also lasted 5 workweeks. A total of four medical examinations were performed throughout the trial period, before and after the first and second trials. A check-up lasts half a day.
Health outcome indicators: height, weight, body composition analysis, saliva, blood pressure, blood, urine sample, stool sample indicators.
Urine, feces and blood samples were collected to detect the relevant indicators in order to explore the potential mechanism of the harm of heavy metals in the hot exposure leaching solution of disposable plastic tableware to human intestinal health.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hot water | Experimental | Other: hot purified water300ml pure water cooled to room temperature in a kettle. |
| normal temperature water | Placebo comparator | Other: hot purified water300 ml pure water without any treatment |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- .Healthy college students aged 18 to 35;
- .Subjects can receive the intervention in this study.
Key exclusion criteria (5 listed)
- 1.Have been diagnosed with diabetes, ulcerative colitis, Crohn's disease, or an infectious disease;
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 |
|---|---|---|
| hot purified waterHot purified water,drink once a workday,almost 360mL.Buy from regular channels. | Other | hot water, normal temperature water |
Primary outcome
Forced Vital Capacity(FVC)
Time frame: Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4weeks plants exposure in second stage
We plan to measure forced vital capacity (FVC) of lung function.
Blood Pressure(BP)
Time frame: Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4weeks plants exposure in second stage.
We plan to measure systolic blood pressure (SBP) and diastolic blood pressure (DBP)
1 secondary outcome
Heart Rate Variability(HRV)
Time frame: Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4weeks plants exposure in second stage.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hot purified water in people with Intestinal Dysfunction and Inflammation, run by Xiang Zeng at 1 site in China.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Forced Vital Capacity(FVC) (time frame: Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4weeks plants exposure in second stage). 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 31 May 2024.