Effects of BPA on Insulin and Glucose Responses

NCT03444922 | Completed

• 1 other identifier: CPJune62018
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The National Institutes of Health has encouraged research examining effects of BPA, yet evidence in humans evaluating the effects of BPA on insulin and glucose concentrations remains exclusively associative in nature. Thus, the primary purpose of this study is to determine whether an acute oral ingestion of BPA impacts insulin and glucose concentrations, and other endocrine factors (Pro-insulin, C-Peptide, Estrogen, triglycerides). Findings from this pilot study will inform public health recommendations for food packaging and provide much needed experimental evidence as to whether BPA poses any public health risk.

Conditions

Environmental Exposure

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Glucose at 180 Minutes

  Glucose concentrations will be assessed before and in response to a 75 gram Oral Glucose Tolerance Test

  9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180

Secondary Outcomes (5)

• Change From Baseline Insulin at 180 Minutes

  9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180

• Change From Baseline Estrogen at 180 Minutes

  9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180

• Change From Baseline C-Peptde at 180 Minutes

  9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180

• Change From Baseline Pro-Insulin at 180 Minutes

  9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180

• Change From Baseline Triglycerides at 180 Minutes

  9 samples over 3 hours at time minutes 0 (baseline), 15, 30, 45, 60, 90, 120, 180

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants consume Vanilla Wafer cookie

Other: Placebo

BPA 4 ug/kg BW

EXPERIMENTAL

Participants consume 4 ug/kg BW of BPA on a Vanilla Wafer Cookie

Other: BPA 4 ug/kg BW

BPA 50 ug/kg BW

EXPERIMENTAL

Participants consume 50 ug/kg BW of BPA on a Vanilla Wafer Cookie

Other: BPA 50 ug/kg BW

Interventions

Placebo OTHER

Ingestion of Placebo

Placebo

BPA 4 ug/kg BW OTHER

Oral BPA ingestion of 4 ug/kg BW

BPA 4 ug/kg BW

BPA 50 ug/kg BW OTHER

Oral BPA ingestion of 50 ug/kg BW

BPA 50 ug/kg BW

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI = 18.5-35
• Age 18-50 years
• Non-smoking
• English speaking

You may not qualify if:

• History of infertility
• Type 2 or Type 1 diabetes
• Cardiovascular disease, or any other metabolic disease/complication
• Hypertension (systolic blood pressure ≥140, diastolic blood pressure ≥90) assessed by sphygmomanometer
• History of major psychiatric illness, drug abuse, or unsafe dieting practices
• History of bariatric surgery
• Pregnant women or women expecting or trying to become pregnant
• Participating in other studies

Sponsors & Collaborators

• California Polytechnic State University-San Luis Obispo: lead

Study Sites (1)

California Polytechnic State University

San Luis Obispo, California, 93405, United States

Location

Study Officials

• Todd Hagobian, PhD

  California Polytechnic State University-San Luis Obispo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Double-blinded study; Study statistician computer generated randomization
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 26, 2018
• Study Start: September 1, 2016
• Primary Completion: February 14, 2019
• Study Completion: February 14, 2019
• Last Updated: February 18, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)