NCT03062163

Brief Summary

To evaluate the lipolysis effect of resveratrol and lipoic acid transdermal patch in overweight volunteers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2017

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

14 days

First QC Date

February 13, 2017

Last Update Submit

February 20, 2017

Conditions

Lipolysis

Outcome Measures

Primary Outcomes (1)

  • fat thickness measured

    fat thickness measurement by ultrasound

    2 weeks

Study Arms (2)

Resveratrol lipoic Acid

EXPERIMENTAL

lipoic and resveratrol was loaded on the patch

Other: Resveratrol lipoic Acid

Placebo

EXPERIMENTAL

normal saline was loaded on transdermal patch

Other: Placebo

Interventions

Resveratrol lipoic AcidOTHER

Transdermal patch loaded with resveratrol and lipoic acid

Resveratrol lipoic Acid
PlaceboOTHER

Transdermal patch loaded with normal saline

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers with BMI \> 23

You may not qualify if:

  • resveratrol or lipoic acid allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, Bangkok, 10330, Thailand

Location

Study Officials

  • Amornpun Sereemaspun, MD., Ph.D

    Chulalongkorn University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 23, 2017

Study Start

January 23, 2017

Primary Completion

February 6, 2017

Study Completion

February 6, 2017

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)