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Clinical Trials/NCT00097253
NCT00097253
Completed
Phase 1

Psychoneuroimmunology and Mind-Body Medicine: Olfaction, Mood, and Physiological Responses

National Center for Complementary and Integrative Health (NCCIH)1 site in 1 country56 target enrollmentAugust 2005

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Stress
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Enrollment
56
Locations
1
Primary Endpoint
Immune Function: Delayed Hypersensitivity to Candida(DTH)
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

The purpose of this study is to examine the body's response to relaxing and stimulating fragrances commonly used in aromatherapy.

Detailed Description

Despite aromatherapy's popularity, efficacy data are scant, and potential mechanisms are controversial. This randomized controlled trial examined the psychological, autonomic, endocrine, and immune consequences of one purported relaxant odor (lavender), one stimulant odor (lemon), and a no-odor control (water), before and after a stressor (cold pressor); 56 healthy men and women were exposed to each of the odors during three separate visits. To assess the effects of expectancies, participants randomized to the "blind" condition were given no information about the odors they would smell; "primed" individuals were told what odors they would smell during the session, and what changes to expect. Experimenters were blind. In each case we measured several different aspects of the cellular immune response, as well as skin barrier repair following tape stripping. This design allowed us to examine the ability of the odors to modulate endocrine and immune function, and health-relevant cutaneous responses.

Registry
clinicaltrials.gov
Start Date
August 2005
End Date
March 2006
Last Updated
16 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Healthy adults with a normal sense of smell

Exclusion Criteria

  • Treatment with medication that has immunological or endocrinological consequences
  • Chronic health problems that affect immune or endocrine systems
  • Allergy to perfume or cosmetics
  • Problems with sense of smell
  • Respiratory problems
  • Current active asthma
  • Use of psychoactive drugs or mood-altering medication
  • History of anxiety disorder, major depression, bipolar disorder, schizophrenia, or other psychotic disorders
  • History of chest pain or ventricular fibrillation

Outcomes

Primary Outcomes

Immune Function: Delayed Hypersensitivity to Candida(DTH)

Time Frame: Day 1 11:45, Day 2 (24h) 11:45, Day 3 (48h) 11:45, Day 4 (72h) 11:45.

DTH memory responses to a common infectious agent provided a measure of T-cell immunity. Nurses inoculated subject's arm with 0.1ml Candida (stock solution diluted 1:20 in saline, Greer Labs, NC) intradermally, after the cold pressor stressor. The wheal diameter (2 dimensions) was self-assessed at 24, 48, and 72 hours by participants given detailed instructions and templates for measurement.

Cortisol and Catecholamine Production

Time Frame: 3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4). Cortisol: 9:05, 10:05, 10:55, 11:45, 12:15, 13:00. Nor/Epi: 9:05, 10:05, 10:55, 11:05, 11:45, 12:15

Cortisol, norepinephrine, epinephrine measured before and after physical (cold pressor) stressor, which occurred at 11:00.

Skin Barrier Repair

Time Frame: 3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4).10:05, 11:45, 13:15

TEWL (Transepidermal Water Loss, via tape stripping procedure)measured before and after cold pressor stressor (11:00). After obtaining baseline measurements on volar forearm, cellophane tape(3M Scotch-type; St. Paul, MN) was applied repeatedly (6-50 times) to remove superficial layer of cornified skin cells. Tape stripping stopped when TEWL was elevated from the basal level of 5-7 g/h/m2 to at least 20 g/h/m2. The number of strips required to reach TEWL X20 g/m2/h was the measure of barrier. TEWL was measured with a computerized evaporimetry instrument, the DermaLabs (CyberDERM, Media, PA).

Immune Function

Time Frame: 3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4). 9:05, 10:05, 11:45

Stimulated Cytokine Production (Interleukin-6 (IL-6), Interleukin-10 (IL-10)) measured before and after cold pressor stressor, which occurred at 11:00.

Study Sites (1)

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