Bisphenol A and Muscle Insulin Sensitivity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2023-12-31

Brief Summary

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This study examine oral bisphenol A consumption on muscle insulin sensitivity and hepatic glucose suppression. Half of the participants will receive a diet plus BPA and the other half will receive a diet plus no bisphenol A.

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Detailed Description

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Evidence linking bisphenol A exposure with diabetes risk remains mainly associative in nature, and mechanism linking bisphenol A to type 2 diabetes remains unclear. The investigator's preliminary data suggests that in young adults, single oral BPA consumption significantly decreased glucose, insulin, and C-Peptide responses to an oral glucose tolerance test, suggesting that immediate consumption of bisphenol A has an effect on muscle insulin sensitivity, hepatic glucose suppression and/or digestion and absorption to lower blood glucose, insulin, and C-Peptide concentrations. The present experimental study evaluating the effects of bisphenol A over several days on the pathogenesis of type 2 diabetes will directly assess each of these potential mechanisms using gold standard measures (euglycemic hyperinsulinemic clamp technique and hepatic glucose suppression with glucose stable isotope infusion, and fecal microbiota).

Conditions

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Insulin Sensitivity Glucose Metabolism Disorders Microtia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This experimental study is a 2-group randomized, clinical trial comparing a 4-day energy balance diet plus oral BPA consumption at 50 ug/kg body weight (Diet+BPA) vs. 4-day energy balance diet plus oral placebo consumption (Diet+No BPA). Forty participants will be randomized to Diet+BPA and Diet+No BPA and will reside in a supervised environment at Cal Poly's sleep research facilities for 6 days (2-day baseline run-in, followed by 4-day treatment). Main outcome measures (muscle insulin sensitivity and hepatic glucose suppression) will be assessed at baseline and treatment periods.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

This study will be a double-blinded study. Research staff collecting data and participants will not know treatment allocation.

Study Groups

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Diet plus bisphenol A

Participants will receive a 4-day diet plus bisphenol A at 50 ug/kg body weight.

Group Type EXPERIMENTAL

bisphenol A

Intervention Type BEHAVIORAL

Vanilla wafer cookie with bisphenol A administered

Placebo

Participants will receive a 4-day diet plus no bisphenol A.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BEHAVIORAL

Vanilla wafer cookie with no bisphenol A

Interventions

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bisphenol A

Vanilla wafer cookie with bisphenol A administered

Intervention Type BEHAVIORAL

Placebo

Vanilla wafer cookie with no bisphenol A

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* non-dieting
* sedentary (≤3 hour/week of aerobic exercise)
* normal-weight (BMI = 18.5 to 24.9 kg/m2)
* weight-stable for the previous 6 months
* free of any metabolic or chronic disease
* non-smoking, and sedentary

Exclusion Criteria

* Hemoglobin A1C based on the American Diabetes Association guidelines of 5.7 to 6.4% (Prediabetes) or \>6.4% (Diabetes)
* impaired glucose tolerance
* type 1 diabetes
* type 2 diabetes
* colitis or any inflammatory bowel condition
* neurologic or psychiatric conditions
* smoking
* special diets (e.g. vegetarian, low-carbohydrate, Paleolithic, etc.)
* pregnant women or women trying to become pregnant

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes