Efficacy and Safety of Resveratrol and Lipoic Acid Transdermal Patch for Lipolysis in Overweight Volunteers

February 20, 2017 updated by: Chulalongkorn University
To evaluate the lipolysis effect of resveratrol and lipoic acid transdermal patch in overweight volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Faculty of Medicine, Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy volunteers with BMI > 23

Exclusion Criteria:

  • resveratrol or lipoic acid allergies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resveratrol lipoic Acid
lipoic and resveratrol was loaded on the patch
Other: Resveratrol lipoic Acid
Transdermal patch loaded with resveratrol and lipoic acid
Experimental: Placebo
normal saline was loaded on transdermal patch
Other: Placebo
Transdermal patch loaded with normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fat thickness measured
Time Frame: 2 weeks
fat thickness measurement by ultrasound
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Study Director: Amornpun Sereemaspun, MD., Ph.D, Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2017

Primary Completion (Actual)

February 6, 2017

Study Completion (Actual)

February 6, 2017

Study Registration Dates

First Submitted

February 13, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nanolab817

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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