ObesityNCT01389869
Appetite Regulation by Human Chemosignals From Tears and Plasma
A study testing Sniffing emotional tears, Sniffing trickled saline and Sniffing fasting plasma in people with Obesity, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Sniffing emotional tears, Sniffing trickled saline and Sniffing fasting plasma
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Sniffing emotional tears, Sniffing trickled saline, Sniffing fasting plasma, Sniffing postprandial plasma
- Keywords
- Emotional tears, Postprandial plasma, Chemosignal, Obesity, Appetite, Food intake
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sniffing emotional tearsBiological
Also called Emotional tears
A band-aid soaked 100μl of emotional tears will be applied just below nostrils.
Sniffing trickled salineBiological
Also called Trickled saline
A band-aid soaked 100μl of trickled saline will be applied just below nostrils.
Sniffing fasting plasmaBiological
Also called Fasting plasma
A band-aid soaked 100μl of own fasting plasma will be applied just below nostrils.
Sniffing postprandial plasmaBiological
Also called Postprandial plasma
A band-aid soaked 100μl of own postprandial plasma will be applied just below nostrils.
| Study group | Role | What they receive |
|---|---|---|
| Tears | Experimental | Emotional tears of female volunteers while watching sad video clips Receives: Biological: Sniffing emotional tears |
| Saline | Placebo comparator | Saline collected after being trickled down women's skin below eyes like tears Receives: Biological: Sniffing trickled saline |
| Fasting | Placebo comparator | Their own overnight fasting plasma of male volunteers Receives: Biological: Sniffing fasting plasma |
| Prandial | Experimental | Their own postprandial plasma of male volunteers Receives: Biological: Sniffing postprandial plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Blood samples for measuring appetite regulating hormones, glucose, testosterone will be collected at -10, 0, and 60 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Min Cho, Seoul National University Hospital
- Investigators
- Young Min Cho, MD, PHD, Study chair, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389869
- Sponsor's protocol ID
- H-1105-011-360
- Status last verified
- Dec 2013
- First submitted
- 6 Jul 2011
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appetite Regulation by Human Chemosignals From Tears and Plasma
- ClinicalTrials.gov ID
- NCT01389869
- Acronym / sponsor ID
- H-1105-011-360
- Conditions
- Obesity
- Keywords
- Emotional tears, Postprandial plasma, Chemosignal, Obesity, Appetite, Food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tears | Experimental | Biological: Sniffing emotional tearsEmotional tears of female volunteers while watching sad video clips |
| Saline | Placebo comparator | Biological: Sniffing trickled salineSaline collected after being trickled down women's skin below eyes like tears |
| Fasting | Placebo comparator | Biological: Sniffing fasting plasmaTheir own overnight fasting plasma of male volunteers |
| Prandial | Experimental | Biological: Sniffing postprandial plasmaTheir own postprandial plasma of male volunteers |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sniffing emotional tearsAlso: Emotional tearsA band-aid soaked 100μl of emotional tears will be applied just below nostrils. | Biological | Tears |
| Sniffing trickled salineAlso: Trickled salineA band-aid soaked 100μl of trickled saline will be applied just below nostrils. | Biological | Saline |
| Sniffing fasting plasmaAlso: Fasting plasmaA band-aid soaked 100μl of own fasting plasma will be applied just below nostrils. | Biological | Fasting |
| Sniffing postprandial plasmaAlso: Postprandial plasmaA band-aid soaked 100μl of own postprandial plasma will be applied just below nostrils. | Biological | Prandial |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Min Cho, MD, PHD study chair
Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sniffing emotional tears, Sniffing trickled saline and Sniffing fasting plasma in people with Obesity, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2013.