- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03260751
Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat
May 7, 2019 updated by: Soo-Wan Chae, Chonbuk National University Hospital
A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat
This study was conducted to investigate the effects of daily supplementation of Zingiber officinale Roscoe extract on body fat.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial.
Forty subjects were randomly divided into Zingiber officinale Roscoe extract 200 mg or placebo group.
The investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and body mass index.
Study Type
Interventional
Enrollment (Actual)
80
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
-
-
Jeollabuk-do
-
Jeonju, Jeollabuk-do, Korea, Republic of, 54907
- Clinical Trial Center for Functional Foods Chonbuk National University Hospital
-
-
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
19 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age between 19 and 65 years,
- BMI 25~29.9 kg/m2
- subjects giving written informed consent
Exclusion Criteria:
- Significant variation in weight(more 10%) in the past 3 months
- Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker
- History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery
- Participation in any other clinical trials within past 2 months
- Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- Pregnancy or breast feeding etc,.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo for 12 weeks
|
Placebo for 12 weeks
|
Experimental: Zingiber officinale Roscoe extract 200 mg
2 cap/day, 800 mg/cap for 12 weeks
|
2 cap/day, 800 mg/cap for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of body fat mass
Time Frame: Baseline and 12 week
|
Body fat mass was measured in study baseline and 12 week
|
Baseline and 12 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of percent body fat
Time Frame: Baseline and 12 week
|
Percent body fat was measured in study baseline and 12 week
|
Baseline and 12 week
|
Changes of fat free mass
Time Frame: Baseline and 12 week
|
Fat Free Mass was measured in study baseline and 12 week
|
Baseline and 12 week
|
Changes of weight
Time Frame: Baseline and 12 week
|
Weight was measured in study baseline and 12 week
|
Baseline and 12 week
|
Changes of body mass index
Time Frame: Baseline and 12 week
|
Body mass index was measured in study baseline and 12 week
|
Baseline and 12 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
February 3, 2017
Primary Completion (Actual)
January 29, 2018
Study Completion (Actual)
January 29, 2018
Study Registration Dates
First Submitted
August 22, 2017
First Submitted That Met QC Criteria
August 22, 2017
First Posted (Actual)
August 24, 2017
Study Record Updates
Last Update Posted (Actual)
May 9, 2019
Last Update Submitted That Met QC Criteria
May 7, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- WJ-BF-ZO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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