ObesityNCT03190785
Benzoates - an Obesogenic Endocrine Disrupting Chemical
A study testing Benzoic acid washout and exposure in people with Obesity and Metabolic Syndrome, run by East Carolina University at 1 site in United States.
Trial summary
The benzoic acid derivatives sodium and potassium benzoate are preservatives that are commonly added to food and beverages to inhibit microbial growth and prevent spoilage. In the US the major source of benzoate intake is beverages. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome
- What is being tested?
- Benzoic acid washout and exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 1 Apr 2021
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young adult (18-30 yrs)
- Healthy non-smoker
- Either overweight (BMI >25 but <30) or obese (BMI >30)
- Has or can obtain transportation to study site
- Able to provide written consent in English
Who cannot join
- Metabolic disease
- Diabetes mellitus
- Hypothyroidism
- Use of medication that may influence metabolism
- Anti-hyperglycemic agents
- Thyroid hormone
Show all 11Show fewer
- Stimulants for ADD/ADHD
- Atypical anti-psychotics
- Weight loss medications
- Benzoate sensitivity
- Known pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27834
About this study
Official title: Benzoic Acid in Beverages: Establishing a Link Between Urinary Metabolites, Metabolic Dysregulation and Weight Loss Failure
The benzoic acid derivatives sodium and potassium benzoate are preservatives that are commonly added to food and beverages to inhibit microbial growth and prevent spoilage. In the US the major source of benzoate intake is beverages. Studies have shown that piglets or chicks fed low levels of benzoic acid have greater feed efficiency and gain more weight than control fed animals. It has also been shown that benzoic acid inhibits the release of a key metabolic hormone, leptin, from isolated adipocytes (fat cells). Inadequate leptin levels result in increased appetite, decreased metabolic rate, weight gain, insulin resistance and increased diabetes risk.
The primary aim of the proposed research is to directly determine if benzoate consumption in human volunteers results in lower levels of leptin, decreased metabolic rate and increased insulin resistance. If so this would implicate benzoic acid as an obesogen and would help inform more effective approaches to obesity prevention and treatment. A secondary aim of the study is to establish a connection between benzoate exposure and biomarkers in urine that can be used to help treat obese patients.
Read the detailed description
Our hypothesis is that benzoic acid is an obesogenic xenobiotic that attenuates the leptin signaling pathway resulting in lower metabolic rate and hence a propensity to weight loss non-responsiveness.
This hypothesis will be addressed in this pilot project via the following Specific Aims:
Aim 1. Determine if dietary benzoate attenuates leptin levels and metabolic rate in human subjects. Twenty heathy adolescents and young adults (age 18-25 yrs.) who are either overweight (BMI 25-29.9) or obese (BMI ≥ 30) will be studied. Following a 14 day period of avoiding benzoate containing beverages (washout period) subjects will then consume 36 oz./day of benzoate containing beverages (~ 3.9 - 4.5 mg benzoate/kg body weight per day exposure) for 7 days (exposure period). Fasting plasma samples will be collected pre and post-exposure and leptin, adiponectin, insulin and glucose levels will be compared. Indirect calorimetry will be used to compare resting energy expenditure pre-and post-exposure.
Aim 2. Validate the use of urinary hippurate and glycine to assess benzoate exposure. An early morning void urine samples will be collected pre-and post-exposure. Non-targeted NMR-based metabolomics analysis will be used to compare changes in individual subject's urinary metabolome using pre- and post-exposure as the "phenotypic" anchors.
- Conditions
- Obesity, Metabolic Syndrome
- Being tested
- Benzoic acid washout and exposure
- Keywords
- benzoic acid, endocrine disrupting chemicals, leptin, metabolic rate
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzoic acid washout and exposureOther
see above
| Study group | Role | What they receive |
|---|---|---|
| Benzoic acid washout and exposure | Experimental | All subjects will be in this arm which employs a pre-post exposure design. Subjects will undergo a 2 week washout period where they avoid consumption of benzoate containing beverages. Then there is a 1 week exposure period comprising daily consumption of benzoate containing beverages to result in up to 5 mg/kg per day benzoic acid intake. Receives: Other: Benzoic acid washout and exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic rate
Metabolic rate as measured by indirect calorimetry
Measured: measured following 1 week dietary exposure to benzoic acid.
Secondary outcomes (1)
Leptin levels
Circulating levels of the adipokine leptin will be measured using ELISA
Measured: measured following 1 week dietary exposure to benzoic acid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start1 Jul 2017
- Primary completion1 Mar 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre/post exposure comparison
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Nash Collier, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190785
- Sponsor's protocol ID
- 17-000376
- Status last verified
- Mar 2023
- First submitted
- 13 Jun 2017
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benzoic Acid in Beverages: Establishing a Link Between Urinary Metabolites, Metabolic Dysregulation and Weight Loss Failure
- ClinicalTrials.gov ID
- NCT03190785
- Acronym / sponsor ID
- 17-000376
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- benzoic acid, endocrine disrupting chemicals, leptin, metabolic rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 19 Jun 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.
The benzoic acid derivatives sodium and potassium benzoate are preservatives that are commonly added to food and beverages to inhibit microbial growth and prevent spoilage. In the US the major source of benzoate intake is beverages. Studies have shown that piglets or chicks fed low levels of benzoic acid have greater feed efficiency and gain more weight than control fed animals. It has also been shown that benzoic acid inhibits the release of a key metabolic hormone, leptin, from isolated adipocytes (fat cells). Inadequate leptin levels result in increased appetite, decreased metabolic rate, weight gain, insulin resistance and increased diabetes risk.
The primary aim of the proposed research is to directly determine if benzoate consumption in human volunteers results in lower levels of leptin, decreased metabolic rate and increased insulin resistance. If so this would implicate benzoic acid as an obesogen and would help inform more effective approaches to obesity prevention and treatment. A secondary aim of the study is to establish a connection between benzoate exposure and biomarkers in urine that can be used to help treat obese patients.
Detailed description
Our hypothesis is that benzoic acid is an obesogenic xenobiotic that attenuates the leptin signaling pathway resulting in lower metabolic rate and hence a propensity to weight loss non-responsiveness.
This hypothesis will be addressed in this pilot project via the following Specific Aims:
Aim 1. Determine if dietary benzoate attenuates leptin levels and metabolic rate in human subjects. Twenty heathy adolescents and young adults (age 18-25 yrs.) who are either overweight (BMI 25-29.9) or obese (BMI ≥ 30) will be studied. Following a 14 day period of avoiding benzoate containing beverages (washout period) subjects will then consume 36 oz./day of benzoate containing beverages (~ 3.9 - 4.5 mg benzoate/kg body weight per day exposure) for 7 days (exposure period). Fasting plasma samples will be collected pre and post-exposure and leptin, adiponectin, insulin and glucose levels will be compared. Indirect calorimetry will be used to compare resting energy expenditure pre-and post-exposure.
Aim 2. Validate the use of urinary hippurate and glycine to assess benzoate exposure. An early morning void urine samples will be collected pre-and post-exposure. Non-targeted NMR-based metabolomics analysis will be used to compare changes in individual subject's urinary metabolome using pre- and post-exposure as the "phenotypic" anchors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre/post exposure comparison
| Arm | Type | Receives |
|---|---|---|
| Benzoic acid washout and exposure | Experimental | Other: Benzoic acid washout and exposureAll subjects will be in this arm which employs a pre-post exposure design. Subjects will undergo a 2 week washout period where they avoid consumption of benzoate containing beverages. Then there is a 1 week exposure period comprising daily consumption of benzoate containing beverages to result in up to 5 mg/kg per day benzoic acid intake. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Young adult (18-30 yrs)
- Healthy non-smoker
- Either overweight (BMI >25 but <30) or obese (BMI >30)
- Has or can obtain transportation to study site
- Able to provide written consent in English
Key exclusion criteria (11 listed)
- Metabolic disease
- Use of medication that may influence metabolism
- Benzoate sensitivity
- Known pregnancy
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 |
|---|---|---|
| Benzoic acid washout and exposuresee above | Other | Benzoic acid washout and exposure |
Primary outcome
Metabolic rate
Time frame: measured following 1 week dietary exposure to benzoic acid.
Metabolic rate as measured by indirect calorimetry
1 secondary outcome
Leptin levels
Time frame: measured following 1 week dietary exposure to benzoic acid
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 24 Mar 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benzoic acid washout and exposure in people with Obesity and Metabolic Syndrome, run by East Carolina University 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 5 inclusion and 11 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 24 Mar 2023. 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?
Metabolic rate (time frame: measured following 1 week dietary exposure to benzoic acid.). 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 24 Mar 2023.