Environmental Exposure Clinical Trial
Official title:
Effects of Oral Ingestion of BPA on Insulin and Glucose Responses
Verified date | February 2019 |
Source | California Polytechnic State University-San Luis Obispo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | February 14, 2019 |
Est. primary completion date | February 14, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | California Polytechnic State University | San Luis Obispo | California |
Lead Sponsor | Collaborator |
---|---|
California Polytechnic State University-San Luis Obispo |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change From Baseline Insulin at 180 Minutes | Insulin 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 | Change From Baseline Estrogen at 180 Minutes | Estrogen 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 | Change From Baseline C-Peptde at 180 Minutes | C-Peptide 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 | Change From Baseline Pro-Insulin at 180 Minutes | Pro-Insulin 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 | Change From Baseline Triglycerides at 180 Minutes | Triglyceride 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 |
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