Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat
A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat
1 other identifier
interventional
80
1 country
1
Brief Summary
This study was conducted to investigate the effects of daily supplementation of Zingiber officinale Roscoe extract on body fat.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Feb 2017
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2017
CompletedFirst Submitted
Initial submission to the registry
August 22, 2017
CompletedFirst Posted
Study publicly available on registry
August 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2018
CompletedMay 9, 2019
May 1, 2019
12 months
August 22, 2017
May 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Changes of body fat mass
Body fat mass was measured in study baseline and 12 week
Baseline and 12 week
Secondary Outcomes (4)
Changes of percent body fat
Baseline and 12 week
Changes of fat free mass
Baseline and 12 week
Changes of weight
Baseline and 12 week
Changes of body mass index
Baseline and 12 week
Study Arms (2)
Zingiber officinale Roscoe extract 200 mg
EXPERIMENTAL2 cap/day, 800 mg/cap for 12 weeks
Placebo
PLACEBO COMPARATORPlacebo for 12 weeks
Interventions
2 cap/day, 800 mg/cap for 12 weeks
Eligibility Criteria
You may qualify if:
- age between 19 and 65 years,
- BMI 25\~29.9 kg/m2
- subjects giving written informed consent
You may not qualify if:
- 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,.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator, Clinical Trial Center for Functional Foods
Study Record Dates
First Submitted
August 22, 2017
First Posted
August 24, 2017
Study Start
February 3, 2017
Primary Completion
January 29, 2018
Study Completion
January 29, 2018
Last Updated
May 9, 2019
Record last verified: 2019-05