Appetite Regulation by Human Chemosignals From Tears and Plasma

NCT01389869 | Completed DMC

• 1 other identifier: H-1105-011-360
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

Emotional tears; Postprandial plasma; Chemosignal; Obesity; Appetite; Food intake

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

• Appetite regulating hormones(ghrelin, GLP-1, PYY), glucose, testosterone. Determination of tears, tickled saline, and plasma.

  Blood samples for measuring appetite regulating hormones, glucose, testosterone will be collected at -10, 0, and 60 min.

Study Arms (4)

Tears

EXPERIMENTAL

Emotional tears of female volunteers while watching sad video clips

Biological: Sniffing emotional tears

Saline

PLACEBO COMPARATOR

Saline collected after being trickled down women's skin below eyes like tears

Biological: Sniffing trickled saline

Fasting

PLACEBO COMPARATOR

Their own overnight fasting plasma of male volunteers

Biological: Sniffing fasting plasma

Prandial

EXPERIMENTAL

Their own postprandial plasma of male volunteers

Biological: Sniffing postprandial plasma

Interventions

Sniffing emotional tears BIOLOGICAL

A band-aid soaked 100μl of emotional tears will be applied just below nostrils.

Also known as: Emotional tears

Tears

Sniffing trickled saline BIOLOGICAL

A band-aid soaked 100μl of trickled saline will be applied just below nostrils.

Also known as: Trickled saline

Saline

Sniffing fasting plasma BIOLOGICAL

A band-aid soaked 100μl of own fasting plasma will be applied just below nostrils.

Also known as: Fasting plasma

Fasting

Sniffing postprandial plasma BIOLOGICAL

A band-aid soaked 100μl of own postprandial plasma will be applied just below nostrils.

Also known as: Postprandial plasma

Prandial

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Young Min Cho, MD, PHD

  Seoul National University College of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Seoul National University

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 8, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: December 9, 2013

Record last verified: 2013-12

Locations

KR (1)