InflammationNCT04600765
hsCRP Clinical Inflammation Marker for Human Bisphenol A Food Contamination
A study testing hsCRP serum measurement of inflammation in people with Inflammation, run by Center for Research on Environmental Chemicals in Humans at 1 site in United States.
Trial summary
Dietary intervention studies thus far have failed to be replicable or causal.This is particularly relevant regarding plastic-derived chemicals (PDCs),This first-of-a-kind dietary intervention study explores a potential causal relationship between human serum levels of BPA and High-Sensitivity C-Reactive Protein (hsCRP) Read more about this study
- Who is it for?
- Ages 60 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- hsCRP serum measurement of inflammation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2019to 10 Dec 2019
- 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 60 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overall good health
- hsCRP below 10
- Standard health review blood panel normal
- BMI less than 25
- % body fat less than 23%
- Resident of North San Francisco Bay area
Show all 11Show fewer
- Willing to eat 100% of all foods and beverages provided.
- No food allergies
- Not taking prescription medications or supplements including daily aspirin.
- Written unformed consent
- Any one not compliant with inclusion criteria.
Who cannot join
- Subject in poor health
- hsCRP above 10
- Standard health review blood panel beyond minimum or maximum limits for any measurement.
- Taking taking prescription medications or supplements including daily aspirin.
- Any evidence of inflammation-linked disease or syndrome including cardiovascular, metabolic syndrome, Type 2 Diabetes, insulin resistance, obesity, auto-immune disease, depression, or other neurological or behavioral disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Research on Environmental Chemicals in Humans
Sonoma, California, 95476
About this study
Official title: Clinical Blood Profile Assays as Biomarkers to Directly Assess Potential Health Effects Resulting From the Controlled Elimination of Suspected Dietary and Environmental Chemical Toxins
Dietary intervention studies thus far have failed to be replicable or causal.This is particularly relevant regarding plastic-derived chemicals (PDCs),This first-of-a-kind dietary intervention study explores a potential causal relationship between human serum levels of BPA and High-Sensitivity C-Reactive Protein (hsCRP)
Read the detailed description
Dietary intervention studies thus far have failed to be replicable or causal. The results, therefore, have failed to provide clinicians and the general public with consistent and useful information on which to base reliable food-related health decisions. This is particularly relevant regarding plastic-derived chemicals (PDCs), such as Bisphenol A, now that the federal CLARITY-BPA program has failed to achieve scientific consensus. Investigators propose a novel human dietary protocol that is both replicable and causal, based upon BPA's demonstrated inflammatory effects in humans. This first-of-a-kind dietary intervention study explores a potential causal relationship between human serum levels of BPA and High-Sensitivity C-Reactive Protein (hsCRP), a proven clinical indicator of inflammation. Investigators used the equivalent of a USDA-defined "typical diet" followed by a PDC-reduced diet to compare blood levels of hsCRP. This proof-of-concept investigation is the first to use an easily accessible, medically-accepted clinical laboratory test to directly measure human health effects of PDC reduction. Unexpected new complications discovered during the investigation indicate that these results may yet be inconclusive for direct causal relationship. However, the novel lessons and techniques developed as a result of those discoveries offer further specific and improved methods and best practices that can enable future dietary interventions to produce replicable, causal results.
- Conditions
- Inflammation
- Being tested
- hsCRP serum measurement of inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hsCRP serum measurement of inflammationDiagnostic test
hsCRP inflammation change as result of non-contaminated diet
| Study group | Role | What they receive |
|---|---|---|
| Diet Before | Active comparator | Typical diet contaminated with Bisphenol A. Patient assigned to this arm will consume a typical American diet as defined by USDA. Receives: Diagnostic Test: hsCRP serum measurement of inflammation |
| Diet After | Active comparator | Bisphenol A reduced. Patient assigned to this arm will consume a diet analogous to atypical American diet as defined by USDA, but with known Bisphenol A sources reduced or eliminated. Receives: Diagnostic Test: hsCRP serum measurement of inflammation |
What is being measured
The primary outcome is the main question the study is designed to answer.
hsCRP Serum concentration vs serum Bisphenol A concentration
Will decreasing Bisphenol A concentration in subject diet alter inflammatinn measure
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start25 Nov 2019
- Primary completion6 Dec 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Research on Environmental Chemicals in Humans
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Lewis Perdue III, Center for Research on Environmental Chemicals in Humans
- Investigators
- WILLIAM L PERDUE, Principal investigator, Center for Research on Environmental Chemicals in HumansVictor I Reus, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600765
- Sponsor's protocol ID
- UCSF-IRB-IRB-15-17703
- Status last verified
- Jan 2021
- First submitted
- 19 Oct 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Because this is an n-of-1, proof of concept study, all data will be share upon request
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Blood Profile Assays as Biomarkers to Directly Assess Potential Health Effects Resulting From the Controlled Elimination of Suspected Dietary and Environmental Chemical Toxins
- ClinicalTrials.gov ID
- NCT04600765
- Acronym / sponsor ID
- UCSF-IRB-IRB-15-17703
- Conditions
- Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Center for Research on Environmental Chemicals in HumansUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 23 Oct 2020 (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.
Dietary intervention studies thus far have failed to be replicable or causal.This is particularly relevant regarding plastic-derived chemicals (PDCs),This first-of-a-kind dietary intervention study explores a potential causal relationship between human serum levels of BPA and High-Sensitivity C-Reactive Protein (hsCRP)
Detailed description
Dietary intervention studies thus far have failed to be replicable or causal. The results, therefore, have failed to provide clinicians and the general public with consistent and useful information on which to base reliable food-related health decisions. This is particularly relevant regarding plastic-derived chemicals (PDCs), such as Bisphenol A, now that the federal CLARITY-BPA program has failed to achieve scientific consensus. Investigators propose a novel human dietary protocol that is both replicable and causal, based upon BPA's demonstrated inflammatory effects in humans. This first-of-a-kind dietary intervention study explores a potential causal relationship between human serum levels of BPA and High-Sensitivity C-Reactive Protein (hsCRP), a proven clinical indicator of inflammation. Investigators used the equivalent of a USDA-defined "typical diet" followed by a PDC-reduced diet to compare blood levels of hsCRP. This proof-of-concept investigation is the first to use an easily accessible, medically-accepted clinical laboratory test to directly measure human health effects of PDC reduction. Unexpected new complications discovered during the investigation indicate that these results may yet be inconclusive for direct causal relationship. However, the novel lessons and techniques developed as a result of those discoveries offer further specific and improved methods and best practices that can enable future dietary interventions to produce replicable, causal results.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet Before | Active comparator | Diagnostic Test: hsCRP serum measurement of inflammationTypical diet contaminated with Bisphenol A. Patient assigned to this arm will consume a typical American diet as defined by USDA. |
| Diet After | Active comparator | Diagnostic Test: hsCRP serum measurement of inflammationBisphenol A reduced. Patient assigned to this arm will consume a diet analogous to atypical American diet as defined by USDA, but with known Bisphenol A sources reduced or eliminated. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Overall good health
- hsCRP below 10
- Standard health review blood panel normal
- BMI less than 25
- % body fat less than 23%
Key exclusion criteria (5 listed)
- Subject in poor health
- hsCRP above 10
- Standard health review blood panel beyond minimum or maximum limits for any measurement.
- Taking taking prescription medications or supplements including daily aspirin.
- Any evidence of inflammation-linked disease or syndrome including cardiovascular, metabolic syndrome, Type 2 Diabetes, insulin resistance, obesity, auto-immune disease, depression, or other neurological or behavioral disorders.
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 |
|---|---|---|
| hsCRP serum measurement of inflammationhsCRP inflammation change as result of non-contaminated diet | Diagnostic test | Diet After, Diet Before |
Primary outcome
hsCRP Serum concentration vs serum Bisphenol A concentration
Time frame: 6 days
Will decreasing Bisphenol A concentration in subject diet alter inflammatinn measure
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 27 Jan 2021.
- Site for posting study-related information, preliminary findings, and supplemental information.Link provided by the sponsor.
- Site for the Center for Research on Environmental Chemicals in Humans -- the 501(c)(3) non-profit supporting this study.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Because this is an n-of-1, proof of concept study, all data will be share upon request
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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.
WILLIAM L PERDUE principal investigator
Center for Research on Environmental Chemicals in Humans
Victor I Reus, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hsCRP serum measurement of inflammation in people with Inflammation, run by Center for Research on Environmental Chemicals in Humans at 1 site in United States.
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 11 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: finished, as of the sponsor's last update on 27 Jan 2021. 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 United States. 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. 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?
hsCRP Serum concentration vs serum Bisphenol A concentration (time frame: 6 days). 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 27 Jan 2021.