Fat BurnnNCT04043182
EFFECTIVENESS OF ULTRASOUND FOR LOCAL FAT TREATMENT
A study testing ultrassound in people with Fat Burn, run by São Paulo State University at 1 site in Brazil.
Trial summary
It's evident that the literature shows good results on the use of aesthetic ultrasound in the treatment of localized fat, however, little has been explored so far, about possible psychological influences of this method and therefore, it is believed that it is pertinent to elaborate studies that include a placebo… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fat Burn
- What is being tested?
- ultrassound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Jun 2019to 30 Sep 2019
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Additional inclusion criteria included body mass index (BMI) equal to or less than 25.0 kg / m2
- Adipose tissue thickness 2.6 cm or more in the treatment region;
- Preserved elasticity and local tissue integrity;
- In addition, participants had to agree not to change their daily routines during the study.
Who cannot join
- Pregnancy.
- Breastfeeding;
- History of liposuction;
- Lipolysis by injection therapy;
- Abdominoplasty or surgery in the treatment region;
- Weight reduction medication;
Show all 14Show fewer
- Recent surgery in the last 12 months;
- Implantable electrical device;
- Neurosurgical deviation;
- Hernia;
- Sensory loss or dysesthesia in the treatment region;
- Cancer;
- Circulation problems;
- Or chronic systemic disease such as diabetes or metabolic syndrome.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Jaqueline Lopes
Barra do Garças, Mount, 78600-000
Jaqueline Lopes, 66999202206, jaqueee-santosss@hotmail.com
About this study
Official title: ULTRASOUND FOR LOCAL FAT TREATMENT: A RANDOMIZED AND DOUBLE-BLIND CLINICAL TEST, CONTROLLED BY PLACEBO
It's evident that the literature shows good results on the use of aesthetic ultrasound in the treatment of localized fat, however, little has been explored so far, about possible psychological influences of this method and therefore, it is believed that it is pertinent to elaborate studies that include a placebo group, in order to measure the real effects from the exclusive application of ultrasound. Therefore, the objective of this study will be to verify the influence of the application of aesthetic ultrasound in the treatment of localized fat, using for both clinical, biochemical and functional parameters.
Read the detailed description
There will be included 30 participants, female gender, communities between 18 and 30 years, apparently Saudi, local abdominal fat, located in three groups: control (n = 10), experimental (n = 10) and placebo (n = 10) . Or group control não recebeu nenhum type of intervention. No experimental group, 10 sessões de ultrassom (Skinner brand, São Paulo) will be carried out in the previous region for 20 minutes. No placebo group will be applied ultrassom (Skinner brand, São Paulo), pormem com zerada intensities. Anthropometric avaliação e of dobras cutâneas will be carried out at this time before applying the treatment protocol. As skin folds will be measured by means of adipometers.
- Conditions
- Fat Burn
- Being tested
- ultrassound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrassoundProcedure or surgery
The treatment protocol will consist of 10 sessions, lasting 20 minutes. The energy level corresponding to 59 J / cm2 (177 J / cm2) and frequency of 3 MHZ, applied in the anterior region of the abdomen, in a quadrant previously delimited with a ballpoint pen, will be used. The flanks (lateral of the abdomen) will not be treated.
| Study group | Role | What they receive |
|---|---|---|
| group control | No intervention | You will not receive any type of intervention |
| treatment group (ultrasound) | Experimental | Will perform protocols of 10 sessions of ultrasound in the region of abdomen Receives: Procedure: ultrassound |
| placebo group | Placebo comparator | It will perform protocols of 10 sessions of ultrasound in the region of abdomen, but the apparatus will be with zero intensities Receives: Procedure: ultrassound |
What is being measured
The primary outcome is the main question the study is designed to answer.
change abdominal circumference (centimeters-cm), before and after intervention
To measure values corresponding to the waist / quadrile ratio, metric phyta will be used, which will collect measurements in centimeters (cm). Assim, at waist circumference, it will be measured at umbigo height.
Measured: before (day 0) and post protocol (post 8 weeks)
change blood analysis (milligrams per decilitre-mg/dl ) before and after intervention
A biochemical analysis will be carried out with the use of soro from blood collection in the antecubital vein, collected at a quantity of 10 mL as participants in the jejum study did not start and end the treatment as ultrassom. As shown below, BIOPLUS 2000 semi-automatic biochemical method will be evaluated for a dosage of parameters such as Triglycerides, Total Cholesterol, High Density Lipoprotein - HDL and Baixa Densidade Lipoprotein Estimates - LDL and Baixíssima Densidade Lipoprotein - VLDL through calculation formula Friedewald As dosagens will be carried out not the Laboratory of Biochemistry of the University Center of Vale do Araguaia - UNIVAR).
Measured: before (day 0) and post protocol (post 8 weeks)
weight (centimeters-cm)
stadiometer (Sanny, American Medical do Brasil, São Paulo, Brazil).
Measured: before (day 0)
Secondary outcomes (3)
anthropometric characteristics anthropometric characteristics, photometry and personal satisfaction
It will be measured by meio de uma meio de uma balança (Tanita BC554, Iron Man / Inner Scaner, Tanita, Illinois, United States) and a stadiometer (Sanny, American Medical do Brasil, São Paulo, Brazil). In this way, the height will be measured in centimeters and the weight in kilograms.
Measured: before (day 0)
change photometry - reduction of waist measurements before and after intervention
A photograph will be taken with a professional camera of Canon Brand Powershot Sx530 Hs, with a fixed focal length and constant lighting.
Measured: before (day 0) and post protocol (post 8 weeks)
personal satisfaction of the participants treated before and after intervention
A satisfação pessoal will be measured by means of a questionnaire, the objective of which will be to investigate these variables in a subjective way. Assim, the participants will be instructed to trace a 10 cm analog visual scale between two extremes, being 0 or "minimum possível" and 10 indicating "or more possível" for each classification. The satisfaction scale ranges from zero to ten.
Measured: before (day 0) and post protocol (post 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start29 Jun 2019
- Primary completion25 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat BurnStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043182
- Sponsor's protocol ID
- SaoPSU_univar
- Acronym
- n
- Status last verified
- Aug 2019
- First submitted
- 12 Jul 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ULTRASOUND FOR LOCAL FAT TREATMENT: A RANDOMIZED AND DOUBLE-BLIND CLINICAL TEST, CONTROLLED BY PLACEBO
- ClinicalTrials.gov ID
- NCT04043182
- Acronym / sponsor ID
- n / SaoPSU_univar
- Conditions
- Fat Burn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Study start
- 29 Jun 2019 (actual)
- Primary completion
- 25 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 2 Aug 2019 (actual)
- 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.
It's evident that the literature shows good results on the use of aesthetic ultrasound in the treatment of localized fat, however, little has been explored so far, about possible psychological influences of this method and therefore, it is believed that it is pertinent to elaborate studies that include a placebo group, in order to measure the real effects from the exclusive application of ultrasound. Therefore, the objective of this study will be to verify the influence of the application of aesthetic ultrasound in the treatment of localized fat, using for both clinical, biochemical and functional parameters.
Detailed description
There will be included 30 participants, female gender, communities between 18 and 30 years, apparently Saudi, local abdominal fat, located in three groups: control (n = 10), experimental (n = 10) and placebo (n = 10) . Or group control não recebeu nenhum type of intervention. No experimental group, 10 sessões de ultrassom (Skinner brand, São Paulo) will be carried out in the previous region for 20 minutes. No placebo group will be applied ultrassom (Skinner brand, São Paulo), pormem com zerada intensities. Anthropometric avaliação e of dobras cutâneas will be carried out at this time before applying the treatment protocol. As skin folds will be measured by means of adipometers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group control | No intervention | –You will not receive any type of intervention |
| treatment group (ultrasound) | Experimental | Procedure: ultrassoundWill perform protocols of 10 sessions of ultrasound in the region of abdomen |
| placebo group | Placebo comparator | Procedure: ultrassoundIt will perform protocols of 10 sessions of ultrasound in the region of abdomen, but the apparatus will be with zero intensities |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Additional inclusion criteria included body mass index (BMI) equal to or less than 25.0 kg / m2
- Adipose tissue thickness 2.6 cm or more in the treatment region;
- Preserved elasticity and local tissue integrity;
- In addition, participants had to agree not to change their daily routines during the study.
Key exclusion criteria (14 listed)
- Pregnancy.
- Breastfeeding;
- History of liposuction;
- Lipolysis by injection therapy;
- Abdominoplasty or surgery in the treatment region;
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 |
|---|---|---|
| ultrassoundThe treatment protocol will consist of 10 sessions, lasting 20 minutes. The energy level corresponding to 59 J / cm2 (177 J / cm2) and frequency of 3 MHZ, applied in the anterior region of the abdomen, in a quadrant previously delimited with a ballpoint pen, will be used. The flanks (lateral of the abdomen) will not be treated. | Procedure or surgery | placebo group, treatment group (ultrasound) |
Primary outcome
change abdominal circumference (centimeters-cm), before and after intervention
Time frame: before (day 0) and post protocol (post 8 weeks)
To measure values corresponding to the waist / quadrile ratio, metric phyta will be used, which will collect measurements in centimeters (cm). Assim, at waist circumference, it will be measured at umbigo height.
change blood analysis (milligrams per decilitre-mg/dl ) before and after intervention
Time frame: before (day 0) and post protocol (post 8 weeks)
A biochemical analysis will be carried out with the use of soro from blood collection in the antecubital vein, collected at a quantity of 10 mL as participants in the jejum study did not start and end the treatment as ultrassom. As shown below, BIOPLUS 2000 semi-automatic biochemical method will be evaluated for a dosage of parameters such as Triglycerides, Total Cholesterol, High Density Lipoprotein - HDL and Baixa Densidade Lipoprotein Estimates - LDL and Baixíssima Densidade Lipoprotein - VLDL through calculation formula Friedewald As dosagens will be carried out not the Laboratory of Biochemistry of the University Center of Vale do Araguaia - UNIVAR).
weight (centimeters-cm)
Time frame: before (day 0)
stadiometer (Sanny, American Medical do Brasil, São Paulo, Brazil).
3 secondary outcomes
anthropometric characteristics anthropometric characteristics, photometry and personal satisfaction
Time frame: before (day 0)
change photometry - reduction of waist measurements before and after intervention
Time frame: before (day 0) and post protocol (post 8 weeks)
personal satisfaction of the participants treated before and after intervention
Time frame: before (day 0) and post protocol (post 8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Fat Burn
Active, not recruitingPhase 4
A Study to See if an Energy Drink With Caffeine and Green Tea Increases Fat Burning When Exercising
Exercise
Active, not recruitingObservational study
Resting Metabolic Rate in Bodybuilders Using Performance-Enhancing Drugs
Athlete Assessment, Body Composition
Recruiting
Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar
Burns, Contracture Scar
Recruiting
Autologous Point-of-Care Adipose Therapy: Recent Injury
Burns, Contracture Scar
RecruitingPhase 1/2
Scar Remodeling After Burn Injury Using Allogeneic Adipose-derived Stromal Cells
Scar Conditions and Fibrosis of Skin, Scar Quality Assessment and Safety
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrassound in people with Fat Burn, run by São Paulo State University at 1 site in Brazil.
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 4 inclusion and 14 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 2 Aug 2019. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaqueline Lopes, master (66999202206, jaqueee-santosss@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change abdominal circumference (centimeters-cm), before and after intervention (time frame: before (day 0) and post protocol (post 8 weeks)). The study lists 3 primary outcomes in all. 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 2 Aug 2019.