Body FatNCT04023864
Efficacy and Safety of Platycodon Grandiflorus Extract(GCWB107) on Decrease of Body Fat
A study testing Platycodon Grandiflorus Extract(GCWB107) in people with Body Fat, 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 Platycodon grandiflorus extract(GCWB107) on decrease of 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
- Body Fat
- What is being tested?
- Platycodon Grandiflorus Extract(GCWB107)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Oct 2018to 30 Nov 2020
- 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
- Males and females aged between 19 and 65 years at the screening
- Participants who were BMI 25~29.9 kg/m^2
- Participants who have fully understood the information provided about the study voluntarily decided to participate and agreed to comply with precautions
Who cannot join
- Participants who decrease 10% more of weight within 3 months period to the screening examination
- Participants taking for products affecting body weight within 4 weeks before the screening examination(i.e., Improvement of body fat Healthy functional food, contraceptive, steroid drug treatment, female hormone drug treatment) (However, participation is possible after a 4-week withdrawal period prior to the first intake day)
- Participants who drink more than 14 units/week of alcohol intake
- Patients with a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry system, musculoskeletal system, inflammatory and hematologic
- Patients with diabetics who are taking oral hypoglycemic agents and insulin (at the screening)
- Participants with a past history of gastrointestinal diseases (e.g., Crohn's disease) or gastrointestinal surgery (but, excluding simple cecal surgery and hernia surgery) that can affect the absorption of products of the human trial
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- Participants who have a history of clinically significant hypersensitivity to balloon flower and saponin components
- Participants receiving antipsychotic medication within 2 months prior to the screening examination
- Participants who were doubtful about drug abuse
- Participants who have participated in other clinical trials within 3 months prior to the screening examination
- Participants who have SBP≥180 mmHg and DBP≥110 mmHg
- Menopause women
- Participants who show the following relevant results in a Laboratory test
- Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
- Serum Creatinine > 2.0 mg/dl
- Women who are pregnant or breastfeeding
- Women who may become pregnant and have not used appropriate contraceptives
- Participants who the principal investigator judged inappropriate for the participant in this study because of a laboratory test result, etc
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Soo-Wan Chae, MD., PhD, 82-63-259-3040, swchae@jbctc.org
About this study
Official title: A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Platycodon Grandiflorus Extract(GCWB107) on Decrease of Body Fat
This study was conducted to investigate the effects of daily supplementation of Platycodon grandiflorus extract(GCWB107) on decrease of body fat.
Read the detailed description
This study was a 12-week, randomized, double-blind, placebo-controlled human trial. 80 subjects were randomly divided into Platycodon grandiflorus extract(GCWB107) group and a placebo group. It is to evaluate the changes in the displayed evaluation items when taking Platycodon grandiflorus extract(GCWB107) extract once a day, in comparison with taking a placebo.
- Conditions
- Body Fat
- Being tested
- Platycodon Grandiflorus Extract(GCWB107), Placebo
- Keywords
- Platycodon Grandiflorus Extract, Body Fat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platycodon Grandiflorus Extract(GCWB107)Dietary supplement
Once-daily, once a tablet, after meals, for 12 week
PlaceboDietary supplement
Placebo for 12 week
| Study group | Role | What they receive |
|---|---|---|
| Platycodon Grandiflorus Extract(GCWB107) group | Experimental | Once-daily, once a tablet, after meals (900 mg/day, 571 mg/day as a Platycodon Grandiflorus Extract(GCWB107)) Receives: Dietary Supplement: Platycodon Grandiflorus Extract(GCWB107) |
| Placebo group | Placebo comparator | Once-daily, once a tablet, after meals (900 mg/day, 0 mg/day as a Platycodon Grandiflorus Extract(GCWB107)) 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: 0 week and 12 week
Secondary outcomes (5)
Changes of percent body fat
Measurement is made using dual-energy X-ray absorptiometry (DEXA / Hologic Discovery, USA). Left-arm, right arm, left leg, right leg, trunk, total will be reported percent body fat in %.
Measured: 0 week and 12 week
Changes of fat free mass
Measurement is made using dual-energy X-ray absorptiometry (DEXA / Hologic Discovery, USA). Left-arm, right arm, left leg, right leg, trunk, total will be reported fat free mass in g.
Measured: 0 week and 12 week
Changes of Anthropometric indicators
Anthropometric indicators(i.e., weight, body mass index, waist circumference, hip circumference, waist-hip ratio) were measured in study screening, 0 weeks, and 12 weeks.
Measured: Screening, 0 week, and 12 week
Changes of indicator of lipid metabolism
Indicators of lipid metabolism(i.e., Total cholesterol, Triglyceride, LDL-cholesterol, HDL-cholesterol) were measured in the study for 0 weeks and 12 weeks.
Measured: 0 week and 12 week
Changes of Obesity-related hormone index
Obesity-related hormone indexes(i.e., Adiponectin, Leptin)were measured in the study for 0 weeks and 12 weeks.
Measured: 0 week 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 posted18 Jul 2019
- Study start19 Oct 2018
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body FatStudies 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 (estimated)
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
- NCT04023864
- Sponsor's protocol ID
- GCWB-BF-PG
- Status last verified
- Nov 2019
- First submitted
- 16 Jul 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 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 Platycodon Grandiflorus Extract(GCWB107) on Decrease of Body Fat
- ClinicalTrials.gov ID
- NCT04023864
- Acronym / sponsor ID
- GCWB-BF-PG
- Conditions
- Body Fat
- Keywords
- Platycodon Grandiflorus Extract, Body Fat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 18 Jul 2019 (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 Platycodon grandiflorus extract(GCWB107) on decrease of body fat.
Detailed description
This study was a 12-week, randomized, double-blind, placebo-controlled human trial. 80 subjects were randomly divided into Platycodon grandiflorus extract(GCWB107) group and a placebo group. It is to evaluate the changes in the displayed evaluation items when taking Platycodon grandiflorus extract(GCWB107) extract once a day, in comparison with taking a placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platycodon Grandiflorus Extract(GCWB107) group | Experimental | Dietary Supplement: Platycodon Grandiflorus Extract(GCWB107)Once-daily, once a tablet, after meals (900 mg/day, 571 mg/day as a Platycodon Grandiflorus Extract(GCWB107)) |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboOnce-daily, once a tablet, after meals (900 mg/day, 0 mg/day as a Platycodon Grandiflorus Extract(GCWB107)) |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females aged between 19 and 65 years at the screening
- Participants who were BMI 25~29.9 kg/m^2
- Participants who have fully understood the information provided about the study voluntarily decided to participate and agreed to comply with precautions
Key exclusion criteria (18 listed)
- Participants who decrease 10% more of weight within 3 months period to the screening examination
- Participants taking for products affecting body weight within 4 weeks before the screening examination(i.e., Improvement of body fat Healthy functional food, contraceptive, steroid drug treatment, female hormone drug treatment) (However, participation is possible after a 4-week withdrawal period prior to the first intake day)
- Participants who drink more than 14 units/week of alcohol intake
- Patients with a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry system, musculoskeletal system, inflammatory and hematologic
- Patients with diabetics who are taking oral hypoglycemic agents and insulin (at the screening)
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 |
|---|---|---|
| Platycodon Grandiflorus Extract(GCWB107)Once-daily, once a tablet, after meals, for 12 week | Dietary supplement | Platycodon Grandiflorus Extract(GCWB107) group |
| PlaceboPlacebo for 12 week | Dietary supplement | Placebo group |
Primary outcome
Changes of body fat mass
Time frame: 0 week and 12 week
Body fat mass was measured in study baseline and 12 week.
5 secondary outcomes
Changes of percent body fat
Time frame: 0 week and 12 week
Changes of fat free mass
Time frame: 0 week and 12 week
Changes of Anthropometric indicators
Time frame: Screening, 0 week, and 12 week
Changes of indicator of lipid metabolism
Time frame: 0 week and 12 week
Changes of Obesity-related hormone index
Time frame: 0 week and 12 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platycodon Grandiflorus Extract(GCWB107) in people with Body Fat, 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 18 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: status not confirmed, as of the sponsor's last update on 2 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soo Wan Chae, Ph.D., M.D. (82-63-259-3040, soowan@jbnu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of body fat mass (time frame: 0 week 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 2 Dec 2019.