Physiological Effects of Androstadienone Exposure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00553384
First received: November 1, 2007
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

The reason for doing this research is to understand why different people show different responses when they smell an odor called androstadienone. Androstadienone is a chemical found in male sweat. Other studies have shown that smelling this chemical can cause people to experience sweating, changes in skin temperature, and changes in a stress hormone call cortisol. These responses, which are called "physiological effects," are stronger in some people than in others.

We are interested in finding out whether these individual differences are genetic, that is caused by differences in our genes. Humans have about 1000 genes for odorant receptors. These are the molecules that bind and detect odor molecules in our nose and allow us to respond to so many different odors. It has been shown that some of these genes exist in two forms: a functional one and one that has been mutated and is therefore no longer functional.

We think that people who do not respond to a specific odor may carry the non-functional form of the gene for the receptor that detects the odor molecule. To test this idea we want to find people who respond strongly to a specific smell, and compare their odorant receptor genes with those of people who respond weakly to the odor.


Condition
Healthy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Physiological Effects of Androstadienone Exposure

Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Skin temperature, skin conductance and salivary cortisol level. [ Time Frame: Monthly over approximately a 5 month period/volunteer ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The ability to detect odor. [ Time Frame: Monthly over a 5 month period. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood


Enrollment: 68
Study Start Date: December 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Detailed Description:

The study consists of five visits. The first visit is a screening visit at which the eligibility of the subject is determined and a blood sample is taken. At this visit, the subject is also given ovulation test strips and instructions to perform urine-based ovulation self-tests at home for a period of several days following the onset of menstruation. The subject is instructed to test her urine at home until an LH surge is detected.

When the subject ovulates and is available for a visit she will come to the Rockefeller University Hospital within one day of detecting an LH surge for the first of four Test Sessions.

The four Test Sessions are identical with the exception that the subject is exposed to a different odor stimulus.

We will be measuring:

  1. skin temperature
  2. sweating, as measured by skin conductance
  3. salivary cortisol levels.
  4. mood
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy adult women between 18-35 years of age.

Criteria

Inclusion Criteria:

  • Healthy adult women between 18-35 years of age.
  • Only subjects whose threshold to either vanillin or isovaleric acid is in the 90th percentile of the population tested in LVO-0539-0507 and who do not report any clinical conditions that may disturb their sense of smell will be enrolled in the study.

Exclusion Criteria:

  • Use of oral contraceptives over the last 3 months
  • Pregnancy
  • Allergies to odors or fragrances
  • History of nasal illness
  • Irregular menstrual periods
  • History of medical conditions that reduced or abolished sense of smell, such as: head injury, cancer therapy, radiation to the head and neck, or alcoholism.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553384

Locations
United States, New York
The Rockefeller University Hospital
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: Leslie Vosshall, Ph.D. The Rockefeller University
  More Information

No publications provided

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00553384     History of Changes
Other Study ID Numbers: LVO-0619
Study First Received: November 1, 2007
Last Updated: February 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
smell
olfaction
androstadienone
women
pheromones
Healthy Volunteers
Physiological Effects of Androstadienone Exposure

ClinicalTrials.gov processed this record on September 22, 2014