Effects of BPA on Insulin and Glucose Responses

California Polytechnic State University (Cal Poly)

Status: Completed

Conditions: Environmental Exposure

Treatments: Other: BPA 50 ug/kg BW; Other: BPA 4 ug/kg BW; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03444922

CPJune62018

Details and patient eligibility

About

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.

Full description

The prevalence of diabetes is well established affecting >29 million Americans with 90-95% of these individuals diagnosed with type 2 diabetes. The etiology of type 2 diabetes is not fully understood, but clearly diet, physical activity, and genetics play roles. Emerging data suggests a novel hypothesis that synthetic non-persistent endocrine disruptors used in a variety of common consumer goods, including the industry-produced chemical bisphenol A (BPA) play a pivotal role in type 2 diabetes and obesity rates. In support of this hypothesis, National Health and Nutrition Examination Survey (NHANES), Nurses' Health Study II (NHSII), and other cross-sectional data have shown associations between urinary BPA concentrations and type-2 diabetes, pre-diabetes, insulin resistance, and hemoglobin A1c. 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) in the pathogenesis of Type 2 diabetes and cardiovascular disease. 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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11 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants consume Vanilla Wafer cookie

Treatment:

Other: Placebo

BPA 4 ug/kg BW

Experimental group

Description:

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

Treatment:

Other: BPA 4 ug/kg BW

BPA 50 ug/kg BW

Experimental group

Description:

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

Treatment:

Other: BPA 50 ug/kg BW