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Complementary and Alternative Medicine Sauna Detoxification Study: Phase I

NCT01905098 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2015-04-17

No results posted yet for this study

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

Interventions

OTHER

Sauna Detoxification Protocol

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.

OTHER

Observation Sessions

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Bastyr University

    lead OTHER

Principal Investigators

  • Jason Allen, ND, MPH · Bastyr University Research Institute

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-09-30
Completion
2014-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01905098 on ClinicalTrials.gov