Benzoates - an Obesogenic Endocrine Disrupting Chemical

NCT03190785 | Completed

• 1 other identifier: 17-000376
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Metabolic Syndrome

Keywords

benzoic acid; endocrine disrupting chemicals; leptin; metabolic rate

Outcome Measures

Primary Outcomes (1)

• Metabolic rate

  Metabolic rate as measured by indirect calorimetry

  measured following 1 week dietary exposure to benzoic acid.

Secondary Outcomes (1)

• Leptin levels

  measured following 1 week dietary exposure to benzoic acid

Study Arms (1)

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.

Other: Benzoic acid washout and exposure

Interventions

Benzoic acid washout and exposure OTHER

see above

Benzoic acid washout and exposure

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Metabolic disease
• Diabetes mellitus
• Hypothyroidism
• Use of medication that may influence metabolism
• Anti-hyperglycemic agents
• Thyroid hormone
• Stimulants for ADD/ADHD
• Atypical anti-psychotics
• Weight loss medications
• Benzoate sensitivity
• Known pregnancy

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

Brody School of Medicine at East Carolina University

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: Pre/post exposure comparison

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 19, 2017
• Study Start: July 1, 2017
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)