This study is NOT currently recruiting participants.
Number
12-E-0089
Sponsoring Institute
National Institute of Environmental Health Sciences (NIEHS)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 25 Max Age: 45
Referral Letter Required
No
Population Exclusion(s)
Children
Special Instructions
Currently Not Provided
Keywords
Biologic Sample Collection; Metabolism
Recruitment Keyword(s)
Healthy Volunteer; HV
Condition(s)
Healthy Volunteers
Investigational Drug(s)
None
Investigational Device(s)
Intervention(s)
Other: deuterated-Bisphenol A (d-BPA)
Supporting Site
National Institute of Environmental Health Sciences
- Bisphenol A (BPA) is a chemical that is used primarily to make plastics, resins, and thermal paper. Most people are exposed daily to low levels of BPA that leaches into food and water from plastic products, including water and baby bottles. However, not all of the risks of BPA are known. Researchers want to learn more about how BPA acts in the body, and how the body gets rid of BPA.
Objectives:
- To study controlled exposure to BPA and its effects on the body.
Eligibility:
- Healthy, non-obese volunteers between 25 and 45 years of age.
Design:
- Participants will have six visits over about 2 to 4 weeks for this study.
- At the first visit, participants will be screened with a physical exam and blood and urine tests. They will complete a questionnaire about exposure to BPA-containing products. They will also receive a list of medications that should not be taken during the study period.
- The second visit will last about 13 hours. Participants will fast for 8 hours before the visit. They will then have a single dose of d-BPA (a modified form of BPA that is easier to study in the body). Regular blood samples will be taken over the 13-hour visit. All urine will also be collected. Participants will receive breakfast and lunch during the visit.
- Participants will have four follow-up visits. They will collect and store all of their urine between each follow-up visit. Blood samples will be collected at the follow-up visits.
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INCLUSION CRITERIA: Participants meeting all of the following criteria will be considered for admission into this study: --Male or female 25-45 years of age at the time of enrollment. --Able to fast overnight (at least 8 hours). --Able to understand and provide written informed consent in English. --Able to travel to the NIEHS Clinical Research Unit (CRU) for all required study visits. --Male and females of reproductive age agree to use contraception to avoid conceiving a child and agree not to donate eggs or sperm for six months following their participation in the study. EXCLUSION CRITERIA: -Uncontrolled diabetes: --Hemoglobin A1C of greater than or equal to 6.5% or a fasting blood glucose of greater than or equal to 126 mg/dL. -Known liver dysfunction or disease: --ALT - higher than the normative value or determined abnormal by the PI. --AST - higher than the normative value or determined abnormal by the PI. --ALP - higher than the normative value or determined abnormal by the PI. -Known kidney dysfunction or disease: --Estimated Glomerular Filtration Rate (eGFR)- <60 ml/min per the MDRD equation. --Clinically relevant anemia as defined as hemoglobin concentration <13g/dL for males and hemoglobin concentration <11g/dL for females. -Pregnancy: Positive serum quantitative hCG pregnancy test. -Current lactation. -BMI less than or equal to 19 and greater than or equal to 35 -Medication use: Given the widespread use of medications, it may not be practical to instruct subjects to avoid all medication prior to and during the study. Thus, participant exclusion will be based on use of medications within 48 hours of the exposure and for the 6 days following the exposure that affect glucuronidation of the d-BPA dosage: Salicylic acid, acetaminophen, ibuprofen, naproxen, mefenamic acid, diclofenac, gliclazide carbamazepine, valproic acid, cimetidine, sulfasalazine, amoxicillin and erythromycin. -Recent blood donation within the past 8 weeks of the BPA exposure visit (so as not to exceed donation of 10.5 mL/kg or 550 mL over an 8 week period).
Participants meeting all of the following criteria will be considered for admission into this study:
--Male or female 25-45 years of age at the time of enrollment.
--Able to fast overnight (at least 8 hours).
--Able to understand and provide written informed consent in English.
--Able to travel to the NIEHS Clinical Research Unit (CRU) for all required study visits.
--Male and females of reproductive age agree to use contraception to avoid conceiving a child and agree not to donate eggs or sperm for six months following their participation in the study.
EXCLUSION CRITERIA:
-Uncontrolled diabetes:
--Hemoglobin A1C of greater than or equal to 6.5% or a fasting blood glucose of greater than or equal to 126 mg/dL.
-Known liver dysfunction or disease:
--ALT - higher than the normative value or determined abnormal by the PI.
--AST - higher than the normative value or determined abnormal by the PI.
--ALP - higher than the normative value or determined abnormal by the PI.
-Known kidney dysfunction or disease:
--Estimated Glomerular Filtration Rate (eGFR)- <60 ml/min per the MDRD equation.
--Clinically relevant anemia as defined as hemoglobin concentration <13g/dL for males and hemoglobin concentration <11g/dL for females.
-Pregnancy: Positive serum quantitative hCG pregnancy test.
-Current lactation.
-BMI less than or equal to 19 and greater than or equal to 35
-Medication use: Given the widespread use of medications, it may not be practical to instruct subjects to avoid all medication prior to and during the study. Thus, participant exclusion will be based on use of medications within 48 hours of the exposure and for the 6 days following the exposure that affect glucuronidation of the d-BPA dosage: Salicylic acid, acetaminophen, ibuprofen, naproxen, mefenamic acid, diclofenac, gliclazide carbamazepine, valproic acid, cimetidine, sulfasalazine, amoxicillin and erythromycin.
-Recent blood donation within the past 8 weeks of the BPA exposure visit (so as not to exceed donation of 10.5 mL/kg or 550 mL over an 8 week period).
Principal Investigator
Referral Contact
For more information: