Complementary and Alternative Medicine Sauna Detoxification Study: Phase I

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 will vary by individual schedule.
For the purposes of this study, a participant will be considered 'actively enrolled' when
s/he has signed the Full Study Consent Form on the first sauna or observation visit (SV1 or
OV1). Each participant will be actively enrolled for at least 7 weeks, but no more than 22
weeks.

All participants will undergo Phone Screen for eligibility prior to participating in any
study-related visits. Candidates will first be asked for their oral consent to be screened,
and if granted, questioning will continue. If the participant meets pre-screening criteria
assessed on the phone, they will be asked to schedule an In-Person Screening Visit.

Prior to randomization, all participants will participate in an In-Person Screening Visit at
the Bastyr University (BU) Clinical Research Center (CRC) for: informed consent, to have a
blood draw for screening lab analysis, anthropomorphic measurements, a 12-lead ECG
assessment, provide demographic data, and medical history assessment.

If participants remain interested and eligible, they will be randomized into either
Sauna-First Arm or Observation-First Arm within 2 weeks of eligibility ascertainment using
block randomization scheme.

Participants will know that they are in an intervention, but will not know their PCB levels,
or the results of questionnaire assessments until approximately three months after the end
of the study. The PI will review monitoring and AE data, but will be blinded to PCB data
during analysis.

After screening, randomization, and informed consent, study participants in either Arm will
either complete a 3-week observation period followed by a 3-week medically monitored
sauna-based detoxification intervention; or will first complete a 3-week medically monitored
sauna-based detoxification intervention, followed by a 3-week observation period. Each
participant will also have an End of Study Visit at least 7 days after the last study visit
(Sauna or Observation Visit -depending on the Arm).

The sauna will be pre-warmed to 160 Fahrenheit degrees and humidity set to 25% +/- 5%.
Participants will have a scheduled 10-min break every 30 minutes of sauna, during which time
vital signs, symptoms, and fluid intake will be assessed and recorded.

During Sauna Visits weekly lab assessments will be performed to compare participants'
baseline lab values with those during the sauna intervention, and to monitor for safety. In
addition, weekly serum samples will be taken for PCB assessment.

During each Observation Visit a blood draw for Complete Blood Count with Differential
(CBC/D), Comprehensive Metabolic Panel (CMP), and PCBs analysis will be performed, as well
as query for symptoms and MOSES questionnaire will be assessed.

Inclusion Criteria:

- 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 Criteria:

- 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.