ObesityNCT03260751
Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat
A study testing Zingiber officinale Roscoe extract 200 mg in people with Obesity, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
This study was conducted to investigate the effects of daily supplementation of Zingiber officinale Roscoe extract on body fat. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Zingiber officinale Roscoe extract 200 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Feb 2017to 29 Jan 2018
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 19 and 65 years,
- BMI 25~29.9 kg/m2
- subjects giving written informed consent
Who cannot join
- 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,.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Zingiber officinale Roscoe extract 200 mg, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zingiber officinale Roscoe extract 200 mgDietary supplement
2 cap/day, 800 mg/cap for 12 weeks
PlaceboDietary supplement
Placebo for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Zingiber officinale Roscoe extract 200 mg | Experimental | 2 cap/day, 800 mg/cap for 12 weeks Receives: Dietary Supplement: Zingiber officinale Roscoe extract 200 mg |
| Placebo | Placebo comparator | Placebo for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of body fat mass
Body fat mass was measured in study baseline and 12 week
Measured: Baseline and 12 week
Secondary outcomes (4)
Changes of percent body fat
Percent body fat was measured in study baseline and 12 week
Measured: Baseline and 12 week
Changes of fat free mass
Fat Free Mass was measured in study baseline and 12 week
Measured: Baseline and 12 week
Changes of weight
Weight was measured in study baseline and 12 week
Measured: Baseline and 12 week
Changes of body mass index
Body mass index was measured in study baseline and 12 week
Measured: Baseline and 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start3 Feb 2017
- Primary completion29 Jan 2018
- Study completion29 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260751
- Sponsor's protocol ID
- WJ-BF-ZO
- Status last verified
- May 2019
- First submitted
- 22 Aug 2017
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat
- ClinicalTrials.gov ID
- NCT03260751
- Acronym / sponsor ID
- WJ-BF-ZO
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 29 Jan 2018 (actual)
- Study completion
- 29 Jan 2018 (actual)
- First posted
- 24 Aug 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.
This study was conducted to investigate the effects of daily supplementation of Zingiber officinale Roscoe extract on body fat.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zingiber officinale Roscoe extract 200 mg | Experimental | Dietary Supplement: Zingiber officinale Roscoe extract 200 mg2 cap/day, 800 mg/cap for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo for 12 weeks |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 19 and 65 years,
- BMI 25~29.9 kg/m2
- subjects giving written informed consent
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Zingiber officinale Roscoe extract 200 mg2 cap/day, 800 mg/cap for 12 weeks | Dietary supplement | Zingiber officinale Roscoe extract 200 mg |
| PlaceboPlacebo for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Changes of body fat mass
Time frame: Baseline and 12 week
Body fat mass was measured in study baseline and 12 week
4 secondary outcomes
Changes of percent body fat
Time frame: Baseline and 12 week
Changes of fat free mass
Time frame: Baseline and 12 week
Changes of weight
Time frame: Baseline and 12 week
Changes of body mass index
Time frame: Baseline and 12 week
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 9 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zingiber officinale Roscoe extract 200 mg in people with Obesity, run by Chonbuk National University Hospital at 1 site in South Korea.
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 3 inclusion and 6 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 9 May 2019. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Changes of body fat mass (time frame: Baseline and 12 week). 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 9 May 2019.