Hungry-Satiation SituationTEMPNCT00487877
Measurements of Skin Physiological Parameters as Mean of Metabolic Assessment
A study testing SenseWear Pro3 Armband and i-button DS2191 H in people with Hungry-Satiation Situation, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
To investigate the relationship between hungry-satiation situation including meal time and metabolism, skin temerature changing, simpathetic \& para-simpathetic response To investigate the relashionship between hungry-satiation situation including meal time and heart rate Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hungry-Satiation Situation
- What is being tested?
- SenseWear Pro3 Armband and i-button DS2191 H
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2007to Dec 2007
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old
- BMI: 22-30 Kg / m2
Who cannot join
- Any unbalanced chronic disease
- Any infection disease
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
The Unit of clinical Nutrition
Tel Aviv
Nachum Vaisman, Prof., +972-524-266-596, vaisman@tasmc.health.gov.il
About this study
To investigate the relationship between hungry-satiation situation including meal time and metabolism, skin temerature changing, simpathetic \& para-simpathetic response To investigate the relashionship between hungry-satiation situation including meal time and heart rate
- Conditions
- Hungry-Satiation Situation
- Being tested
- SenseWear Pro3 Armband, i-button DS2191 H
- Keywords
- metabolism, temperature changing, skin, heart rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenseWear Pro3 ArmbandDevice
i-button DS2191 HDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2007 (estimated)
- Study startJun 2007
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hungry-Satiation SituationStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Nachum Vaisman, Prof., Principal investigator, unaffiliationNachum Vaisman, Prof., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487877
- Sponsor's protocol ID
- TASMC-06-NV-380-CTIL
- Acronym
- TEMP
- Status last verified
- Dec 2006
- First submitted
- 18 Jun 2007
- Last updated
- 19 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurements of Skin Physiological Parameters as Mean of Metabolic Assessment
- ClinicalTrials.gov ID
- NCT00487877
- Acronym / sponsor ID
- TEMP / TASMC-06-NV-380-CTIL
- Conditions
- Hungry-Satiation Situation
- Keywords
- metabolism, temperature changing, skin, heart rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jun 2007
- Study completion
- Dec 2007 (estimated)
- First posted
- 19 Jun 2007 (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.
To investigate the relationship between hungry-satiation situation including meal time and metabolism, skin temerature changing, simpathetic \& para-simpathetic response To investigate the relashionship between hungry-satiation situation including meal time and heart rate
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18 years old
- BMI: 22-30 Kg / m2
Key exclusion criteria (2 listed)
- Any unbalanced chronic disease
- Any infection disease
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 |
|---|---|---|
| SenseWear Pro3 Armband | Device | – |
| i-button DS2191 H | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2007.
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.
Nachum Vaisman, Prof. principal investigator
unaffiliation
Nachum Vaisman, Prof. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SenseWear Pro3 Armband and i-button DS2191 H in people with Hungry-Satiation Situation, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 19 Jun 2007. 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 Israel. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nachum Vaisman, Prof. (+972-524-266-596, vaisman@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 19 Jun 2007.