Status:
TERMINATED
Complementary and Alternative Medicine Sauna Detoxification Study: Phase I
Lead Sponsor:
Bastyr University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Hyperthermia
Eligibility:
All Genders
21-35 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the impact of sauna use on polychlorinated biphenyls (PCB) in the blood of healthy human adults, as well as to assess safety, feasibility, and tolerability, a...
Detailed Description
This is a Phase I, 2-Arm randomized trial. All study participants will actively undergo sauna intervention sessions and observation sessions. The time between Phone Screen and the End of Study Visit...
Eligibility Criteria
Inclusion
- 21-35 years.
- Body mass index (BMI) 19 to 29.9 kg/m2 at the screening evaluation.
- Ability to schedule and attend daily visits for the duration of the study.
- If female, willingness to use barrier contraception (e.g., cervical cap, diaphragm, condom, metal (non- hormone) Intrauterine Device (IUD) throughout the study and take a pregnancy test at screening and weekly during the study.
Exclusion
- Pregnant, or trying to become pregnant in the three months following screening.
- Current use of any prescribed pharmaceutical medications (including oral contraceptive pills (OCPs) and dietary supplements).
- Refusal to stop taking self-prescribed dietary supplements and OCPs for the duration of the study.
- BMI greater than 29.9 kg/m2 or less than 19 kg/m2.
- Elevated fasting blood sugar (above 125 mg/dL).
- Abnormal ECG findings of: bradycardia (heart rate below 60) not due to athletic bradycardia, ventricular arrhythmias, axis deviation, coronary circulation problems (ischemia/infarct/injury), or any activation sequence disorders (e.g. Right/Left Bundle Branch Block (RBBB/LBBB) and Wolff-Parkinson-White Syndrome (WPW).)
- Hyper or hypotension (BP above 180/100 or below 80/50 respectively).
- A reported diagnosis of any chronic medical condition (e.g., multiple sclerosis, diabetes, or endocrine disorders, liver disease, kidney disease, HIV/AIDS, or cancer), or with a reported history of substance abuse or mental illness within the past 5 years, or a mental health disorder in the past 6 months.
- CBC/D, ALT-Liver Protein, AST-Liver Protein, Blood Urea Nitrogen (BUN), or Creatinine outside of 15% of the Lower/Upper Limit of Normal (LLN/ULN) values.
- Recent infection (\<14 days), open sores, or communicable skin conditions.
- Current reported use of any tobacco products or illicit drugs.
- Any condition that, in the opinion of the investigators or Institutional Review Board (IRB), would preclude the safe completion of the study (e.g., clinical or mental health concerns that arise from the overall screening or medical history assessment).
- Previous participation in the pilot sauna detoxification study, and/or participation in a detoxification program within the last 6 months of the Phone Screen.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01905098
Start Date
July 1 2013
End Date
April 1 2014
Last Update
April 17 2015
Active Locations (1)
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1
Bastyr University Research Institute, Clinical Research Center
Kenmore, Washington, United States, 98028