Body FatNCT06422013
Clinical Study to Evaluate the Body Fat Reducing Effect and Safety of GTB1
A study testing GTB1 in people with Body Fat, run by Amorepacific Corporation at 1 site in South Korea.
Trial summary
This study was conducted to investigate the effects of daily supplementation of GTB1 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?
- GTB1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Oct 2022to 8 Dec 2023
- 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 19~65 years at the screening
- Participants who were BMI 25.0~34.9 kg/m^2 (Excluding those who need to take or be prescribed medication that affects fat reduction, if the BMI is between 30.0~34.9 kg/m^2)
- Participants who have a waist circumference of 90 cm for men and 85 cm or more for women
- 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
- Participants who have undergone surgical procedures (such as gastrectomy) for weight loss
- Participants who have a history of malignant tumors within 5 years prior to participating in the clinical study
- Participants who have a systolic blood pressure of 160 mmHg or higher, or a diastolic blood pressure of 100 mmHg or higher (those who are stably controlling their blood pressure with medication can participate)
- Participants who are taking beta-blockers or diuretics as part of their hypertension treatment
- Patients who have been diagnosed with Type 1 or Type 2 diabetes and are taking oral hypoglycemic agents and insulin
Show all 17Show fewer
- Participants who have taken antibiotics within 4 weeks prior to the screening examination
- Participants who have taken health functional foods, herbal medicine, or general foods for the purpose of weight loss within 4 weeks prior to the screening visit
- Participants with clinically significant acute or chronic diseases of the cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry system, musculoskeletal system, inflammatory and hematologic, gastrointestinal diseases, and other diseases requiring treatment
- 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
- Participants who have participated in other clinical study within 3 months prior to the screening examination
- Women who are pregnant or breastfeeding
- Women who may become pregnant and have not used appropriate contraceptives
- 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
- 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
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Body Fat Reducing Effect and Safety of Lactiplantibacillus Plantarum APsulloc 331261(GTB1)
This study was conducted to investigate the effects of daily supplementation of GTB1 on decrease of body fat.
Read the detailed description
This study was a 12 week, randomized, double-blind, placebo-controlled human trial. 100 subjects were randomly divided into GTB1 group and placebo group. It is to evaluate the changes in the displayed evaluation items when taking GTB1 once a day, in comparison with taking a placebo.
- Conditions
- Body Fat
- Being tested
- GTB1, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTB1Dietary supplement
oral administration of GTB1 powder packet once daily
PlaceboDietary supplement
oral administration of placebo powder packet once daily
| Study group | Role | What they receive |
|---|---|---|
| GTB1 | Active comparator | Once-daily, once a packet, for 12 week Receives: Dietary Supplement: GTB1 |
| Placebo | Placebo comparator | Once-daily, once a packet, for 12 week Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of percent body fat(trunk, total ect.)
Measurement is made using dual-energy X-ray absorptiometry(DEXA)
Measured: Baseline, Week 12
Secondary outcomes (5)
Changes of fat free mass(trunk, total ect.)
Measurement of the target area is made using dual-energy X-ray absorptiometry (DEXA)
Measured: Baseline, Week 12
Changes of total abdominal fat area, visceral fat area and subcutaneous fat area
Measurement of the target area is made using computed tomography (CT)
Measured: Baseline, Week 12
Changes of waist, hip circumference and waist/hip circumference ratio
Measurement of waist and hip circumference is performed following the WHO guideline
Measured: Baseline, Week 12
Changes of indicator of lipid metabolism
Indicator of lipid metabolism(i.e., Total cholesterol, Triglyceride, LDL-cholesterol, HDL-cholesterol)
Measured: Baseline, Week 12
Changes of obesity-related hormone index
Obesity-related hormone indexes(Adiponectin, Leptin etc.). As blood adiponectin levels increase, blood leptin concentrations decrease, indicating a positive change.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start28 Oct 2022
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422013
- Sponsor's protocol ID
- AP-PV-2022-01
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Body Fat Reducing Effect and Safety of Lactiplantibacillus Plantarum APsulloc 331261(GTB1)
- ClinicalTrials.gov ID
- NCT06422013
- Acronym / sponsor ID
- AP-PV-2022-01
- Conditions
- Body Fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 20 May 2024 (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 GTB1 on decrease of body fat.
Detailed description
This study was a 12 week, randomized, double-blind, placebo-controlled human trial. 100 subjects were randomly divided into GTB1 group and placebo group. It is to evaluate the changes in the displayed evaluation items when taking GTB1 once a day, in comparison with taking a placebo.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GTB1 | Active comparator | Dietary Supplement: GTB1Once-daily, once a packet, for 12 week |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOnce-daily, once a packet, for 12 week |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females aged between 19~65 years at the screening
- Participants who were BMI 25.0~34.9 kg/m^2 (Excluding those who need to take or be prescribed medication that affects fat reduction, if the BMI is between 30.0~34.9 kg/m^2)
- Participants who have a waist circumference of 90 cm for men and 85 cm or more for women
- Participants who have fully understood the information provided about the study voluntarily decided to participate and agreed to comply with precautions
Key exclusion criteria (17 listed)
- Participants who decrease 10% more of weight within 3 months period to the screening
- Participants who have undergone surgical procedures (such as gastrectomy) for weight loss
- Participants who have a history of malignant tumors within 5 years prior to participating in the clinical study
- Participants who have a systolic blood pressure of 160 mmHg or higher, or a diastolic blood pressure of 100 mmHg or higher (those who are stably controlling their blood pressure with medication can participate)
- Participants who are taking beta-blockers or diuretics as part of their hypertension treatment
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 |
|---|---|---|
| GTB1oral administration of GTB1 powder packet once daily | Dietary supplement | GTB1 |
| Placebooral administration of placebo powder packet once daily | Dietary supplement | Placebo |
Primary outcome
Changes of percent body fat(trunk, total ect.)
Time frame: Baseline, Week 12
Measurement is made using dual-energy X-ray absorptiometry(DEXA)
5 secondary outcomes
Changes of fat free mass(trunk, total ect.)
Time frame: Baseline, Week 12
Changes of total abdominal fat area, visceral fat area and subcutaneous fat area
Time frame: Baseline, Week 12
Changes of waist, hip circumference and waist/hip circumference ratio
Time frame: Baseline, Week 12
Changes of indicator of lipid metabolism
Time frame: Baseline, Week 12
Changes of obesity-related hormone index
Time frame: Baseline, Week 12
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 22 May 2024.
- Individual participant dataSharing planned: No
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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 GTB1 in people with Body Fat, run by Amorepacific Corporation 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 4 inclusion and 17 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 22 May 2024. 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 percent body fat(trunk, total ect.) (time frame: Baseline, Week 12). 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 22 May 2024.