Appetite Regulation by Human Chemosignals From Tears and Plasma - Full Text View

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:

MedlinePlus related topics: Obesity

U.S. FDA Resources

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 ]

Estimated Enrollment:	20
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

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/Assistant Professor, Seoul National University College of Medicine
ClinicalTrials.gov Identifier:	NCT01389869 History of Changes
Other Study ID Numbers:	H-1105-011-360
Study First Received:	July 6, 2011
Last Updated:	February 20, 2012
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 May 19, 2013