Complementary and Alternative Medicine Sauna Detoxification Study: Phase I

Stopped early · Phase 1

Conditions studied: Hyperthermia

In brief

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, and effects on quality of life and wellness. We hope to determine if there is a link between lower PCB levels in blood and sauna use.

Key facts

Study ID

NCT01905098

Run by

Bastyr University

People needed

1

Starts

2013-07-01

Expected to finish

2014-04-01

Last updated by the study team

2015-04-17

Who can join

Age: 21 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bastyr University Research Institute, Clinical Research Center — Kenmore, Washington, United States

Full record on ClinicalTrials.gov

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