Appetite Regulation by Human Chemosignals From Tears and Plasma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Young Min Cho, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01389869
First received: July 6, 2011
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Obesity
Biological: Sniffing emotional tears
Biological: Sniffing trickled saline
Biological: Sniffing fasting plasma
Biological: Sniffing postprandial plasma

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: June 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tears
Emotional tears of female volunteers while watching sad video clips
Biological: Sniffing emotional tears
A band-aid soaked 100μl of emotional tears will be applied just below nostrils.
Other Name: Emotional tears
Placebo Comparator: Saline
Saline collected after being trickled down women's skin below eyes like tears
Biological: Sniffing trickled saline
A band-aid soaked 100μl of trickled saline will be applied just below nostrils.
Other Name: Trickled saline
Placebo Comparator: Fasting
Their own overnight fasting plasma of male volunteers
Biological: Sniffing fasting plasma
A band-aid soaked 100μl of own fasting plasma will be applied just below nostrils.
Other Name: Fasting plasma
Experimental: Prandial
Their own postprandial plasma of male volunteers
Biological: Sniffing postprandial plasma
A band-aid soaked 100μl of own postprandial plasma will be applied just below nostrils.
Other Name: Postprandial plasma

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01389869

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Chair: Young Min Cho, MD, PHD Seoul National University College of Medicine
  More Information

No publications provided

Responsible Party: Young Min Cho, Seoul National University, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01389869     History of Changes
Other Study ID Numbers: H-1105-011-360
Study First Received: July 6, 2011
Last Updated: December 5, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Emotional tears
Postprandial plasma
Chemosignal
Obesity
Appetite
Food intake

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014