Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 12 for:    Endocrine Disruptors

Benzoates - an Obesogenic Endocrine Disrupting Chemical

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03190785
Recruitment Status : Unknown
Verified June 2017 by David Nash Collier, East Carolina University.
Recruitment status was:  Recruiting
First Posted : June 19, 2017
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
David Nash Collier, East Carolina University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Obesity Metabolic Syndrome Other: Benzoic acid washout and exposure Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pre/post exposure comparison
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Benzoic Acid in Beverages: Establishing a Link Between Urinary Metabolites, Metabolic Dysregulation and Weight Loss Failure
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Benzoic acid washout and exposure
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.
Other: Benzoic acid washout and exposure
see above




Primary Outcome Measures :
  1. Metabolic rate [ Time Frame: measured following 1 week dietary exposure to benzoic acid. ]
    Metabolic rate as measured by indirect calorimetry


Secondary Outcome Measures :
  1. Leptin levels [ Time Frame: measured following 1 week dietary exposure to benzoic acid ]
    Circulating levels of the adipokine leptin will be measured using ELISA



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Metabolic disease

    1. Diabetes mellitus
    2. Hypothyroidism
  • Use of medication that may influence metabolism

    1. Anti-hyperglycemic agents
    2. Thyroid hormone
    3. Stimulants for ADD/ADHD
    4. Atypical anti-psychotics
    5. Weight loss medications
  • Benzoate sensitivity
  • Known pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190785


Contacts
Layout table for location contacts
Contact: David N Collier, MD, PhD 252 744 4994 collierd@ecu.edu
Contact: Patricia Brophy, MS 252 737 1600 brophyp@ecu.edu

Locations
Layout table for location information
United States, North Carolina
Brody School of Medicine at East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: David N Collier, MD, PhD    252-744-4994    collierd@ecu.edu   
Contact: Patricia Brophy, MS    252 737 1600    brophyp@ecu.edu   
Sponsors and Collaborators
East Carolina University

Layout table for additonal information
Responsible Party: David Nash Collier, Associate Professor of Pediatrics, East Carolina University
ClinicalTrials.gov Identifier: NCT03190785     History of Changes
Other Study ID Numbers: 17-000376
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Nash Collier, East Carolina University:
benzoic acid
endocrine disrupting chemicals
leptin
metabolic rate

Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Benzoic Acid
Endocrine Disruptors
Antifungal Agents
Anti-Infective Agents
Physiological Effects of Drugs