LipolysisNCT03062163
Efficacy and Safety of Resveratrol and Lipoic Acid Transdermal Patch for Lipolysis in Overweight Volunteers
A study testing Resveratrol lipoic Acid in people with Lipolysis, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
To evaluate the lipolysis effect of resveratrol and lipoic acid transdermal patch in overweight volunteers Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipolysis
- What is being tested?
- Resveratrol lipoic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteThailand
- Study dates
- 23 Jan 2017to 6 Feb 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers with BMI > 23
Who cannot join
- resveratrol or lipoic acid allergies
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Chulalongkorn University
Bangkok, Bangkok, 10330
About this study
To evaluate the lipolysis effect of resveratrol and lipoic acid transdermal patch in overweight volunteers
Read the detailed description
66 participants with overweight received a resveratrol and lipoic acid transdermal patch treatment. The treatment areas have been treated including left and right arms. Subjects were evaluated using standardized measurements of body weight and circumference of arms at baseline and 2 weeks follow-up visits. Evaluation of physician were also measured.
- Conditions
- Lipolysis
- Being tested
- Resveratrol lipoic Acid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resveratrol lipoic AcidOther
Transdermal patch loaded with resveratrol and lipoic acid
PlaceboOther
Transdermal patch loaded with normal saline
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol lipoic Acid | Experimental | lipoic and resveratrol was loaded on the patch Receives: Other: Resveratrol lipoic Acid |
| Placebo | Experimental | normal saline was loaded on transdermal patch Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
fat thickness measured
fat thickness measurement by ultrasound
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start23 Jan 2017
- Primary completion6 Feb 2017
- Study completion6 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipolysisStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amornpun Sereemaspun, MD., Ph.D, Study director, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062163
- Sponsor's protocol ID
- nanolab817
- Status last verified
- Feb 2017
- First submitted
- 13 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Resveratrol and Lipoic Acid Transdermal Patch for Lipolysis in Overweight Volunteers
- ClinicalTrials.gov ID
- NCT03062163
- Acronym / sponsor ID
- nanolab817
- Conditions
- Lipolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 6 Feb 2017 (actual)
- Study completion
- 6 Feb 2017 (actual)
- First posted
- 23 Feb 2017 (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.
To evaluate the lipolysis effect of resveratrol and lipoic acid transdermal patch in overweight volunteers
Detailed description
66 participants with overweight received a resveratrol and lipoic acid transdermal patch treatment. The treatment areas have been treated including left and right arms. Subjects were evaluated using standardized measurements of body weight and circumference of arms at baseline and 2 weeks follow-up visits. Evaluation of physician were also measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol lipoic Acid | Experimental | Other: Resveratrol lipoic Acidlipoic and resveratrol was loaded on the patch |
| Placebo | Experimental | Other: Placebonormal saline was loaded on transdermal patch |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers with BMI > 23
Key exclusion criteria (1 listed)
- resveratrol or lipoic acid allergies
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 |
|---|---|---|
| Resveratrol lipoic AcidTransdermal patch loaded with resveratrol and lipoic acid | Other | Resveratrol lipoic Acid |
| PlaceboTransdermal patch loaded with normal saline | Other | Placebo |
Primary outcome
fat thickness measured
Time frame: 2 weeks
fat thickness measurement by ultrasound
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 23 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Lipolysis
Not yet recruiting
Pilot Study of Naringenin Beta Carotene Cream for Local Fat Reduction (SCULPT)
Thigh Cellulite
RecruitingPhase 2
Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance
Insulin Receptor Mutation, Partial Lipodystrophy
RecruitingPhase 3
SGLT2i, Pioglitazone, and Ketone Production in T1D
Type1diabetes
RecruitingPhase 1
SGLTi, Hepatic Glucose Production and Ketogenesis
Type 2 Diabetes
RecruitingPhase 1
SGLT2i, Ketoacidosis, Volume Contraction, and Insulinopenia
Type 2 Diabetes
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.
Amornpun Sereemaspun, MD., Ph.D study director
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resveratrol lipoic Acid in people with Lipolysis, run by Chulalongkorn University at 1 site in Thailand.
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 1 inclusion and 1 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 23 Feb 2017. 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 Thailand. 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?
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?
fat thickness measured (time frame: 2 weeks). 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 23 Feb 2017.