Complementary and Alternative Medicine Sauna Detoxification Study: Phase I

NCT01905098 | Terminated Phase 1 DMC

• 2 other identifiers: H35B11-Phase15R00AT004711-04
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Hyperthermia

Keywords

Detoxification; Sauna; Hyperthermia

Outcome Measures

Primary Outcomes (2)

• Impact of sauna protocol on PCB levels

  The primary comparison measure will be PCB levels at Sauna Visit 15 in the sauna-first Arm and Observation Visit 4 in the Observation-First Arm.

  6 weeks

• Safety

  To evaluate the safety of sauna detoxification by recording and describing all adverse events (AE's) throughout the study.

  6 weeks

Secondary Outcomes (1)

• Participant-Reported Symptoms

  6 weeks

Study Arms (2)

Observation-First Arm

EXPERIMENTAL

A group that first attends 4 observation visits without sauna, and then attends sauna sessions 5 times a week for 3.5 hours per visit for 3 weeks. Participants in this Arm will undergo both listed interventions: Observation and Sauna Protocols.

Other: Sauna Detoxification Protocol; Other: Observation Sessions

Sauna-First Arm

ACTIVE COMPARATOR

A group that first attends sauna sessions 5 times a week for 3.5 hours per visit for 3 weeks and then attends 4 observation visits without sauna. Participants in this Arm will undergo both listed interventions: Observation and Sauna Protocols.

Other: Sauna Detoxification Protocol; Other: Observation Sessions

Interventions

Sauna Detoxification Protocol OTHER

All study participants will actively undergo sauna intervention sessions. The sauna will be pre-warmed to 160 degrees Fahrenheit 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. On a weekly basis, 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.

Also known as: Sauna-based detoxification

Observation-First Arm; Sauna-First Arm

Observation Sessions OTHER

All enrolled participants will undergo observation protocol consisting of one (1) hour visit weekly consistent with Sauna Visits lab assessment time points, to be completed in 3 weeks (4 total sessions within 21 days). At each Observation Visit a blood draw for CBC/D, CMP, and PCBs analysis will be performed, as well as query for symptoms and MOSES questionnaire will be assessed.

Observation-First Arm; Sauna-First Arm

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Bastyr University: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Bastyr University Research Institute, Clinical Research Center

Kenmore, Washington, 98028, United States

Location

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Jason Allen, ND, MPH

  Bastyr University Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: July 23, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: April 1, 2014
• Last Updated: April 17, 2015

Record last verified: 2015-04

Locations

US (1)