- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01389869
Appetite Regulation by Human Chemosignals From Tears and Plasma
December 5, 2013 updated by: Young Min Cho, Seoul National University Hospital
Obesity is closely related to metabolic diseases and its prevalence is sharply increasing.
However, there is no safe and effective treatment for obesity so far, the investigators need a breakthrough idea to curtail the constant threat of obesity.
It has been recently demonstrated that emotional tears of women can modify sexual responses, one of basic instincts, in men.
As appetite and food intake is another basic instinct, chemosignals from tears and plasma may modify appetite and eating behavior in humans.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Woman: Negative for HIV, Syphilis (VDRL), and Hepatitis B and C
- Man: Has a body mass index (BMI) of 18.5 kg/m2 to 27 kg/m2, inclusive.
Exclusion Criteria:
- Woman: Has eyelids inflammation, conjunctivitis, keratitis, lacrimal duct obstruction. Has skin diseases around eyes.
- Man: Has diabetes mellitus or dyslipidemia on medication. Received gastrointestinal surgery except appendectomy and hemorrhoidectomy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tears
Emotional tears of female volunteers while watching sad video clips
|
A band-aid soaked 100μl of emotional tears will be applied just below nostrils.
Other Names:
|
|
Placebo Comparator: Saline
Saline collected after being trickled down women's skin below eyes like tears
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A band-aid soaked 100μl of trickled saline will be applied just below nostrils.
Other Names:
|
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Placebo Comparator: Fasting
Their own overnight fasting plasma of male volunteers
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A band-aid soaked 100μl of own fasting plasma will be applied just below nostrils.
Other Names:
|
|
Experimental: Prandial
Their own postprandial plasma of male volunteers
|
A band-aid soaked 100μl of own postprandial plasma will be applied just below nostrils.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The degree of appetite by visual analogue scale (VAS) and the amount of food intake by standard test meals in male volunteers while sniffing tears, trickled saline (control), and postprandial and fasting plasma in random order.
Time Frame: Visual analogue scale (VAS) will be rated 10 minutes after initial sniffing of tears/plasma just before eating standard test meals. The amount of food intake will be measured by weighing the meals before and after eating.
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Visual analogue scale (VAS) will be rated 10 minutes after initial sniffing of tears/plasma just before eating standard test meals. The amount of food intake will be measured by weighing the meals before and after eating.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Appetite regulating hormones(ghrelin, GLP-1, PYY), glucose, testosterone. Determination of tears, tickled saline, and plasma.
Time Frame: Blood samples for measuring appetite regulating hormones, glucose, testosterone will be collected at -10, 0, and 60 min.
|
Blood samples for measuring appetite regulating hormones, glucose, testosterone will be collected at -10, 0, and 60 min.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Young Min Cho, MD, PHD, Seoul National University College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
July 6, 2011
First Submitted That Met QC Criteria
July 7, 2011
First Posted (Estimate)
July 8, 2011
Study Record Updates
Last Update Posted (Estimate)
December 9, 2013
Last Update Submitted That Met QC Criteria
December 5, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-1105-011-360
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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