ObesityNCT03826212
Efficacy and Safety of Soybean Germ Extract on Decrease of Body Fat
A study testing Soybean Germ Extract 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 Soybean germ extract 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
- Obesity
- What is being tested?
- Soybean Germ Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jun 2019to 28 Feb 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
- age between 19 and 65 years
- BMI 25~29.9 kg/m^2
- After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice
Who cannot join
- Those who lost more than 10% of their weight within 3 months before the screening
- Those who take a product(body fat improvement health functional foods, birth control pills, steroids, female hormone) that affects your weight within 4 weeks prior to the screening
- Those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
- Diabetic patients taking oral hypoglycemic agents or insulin (based on screening subjects)
- A person with a history of clinically significant hypersensitivity to soybeans
- Those who have received antipsychotic medication within 2 months before screening
Show all 16Show fewer
- Anyone with substance abuse or suspicion
- Those who participated in other clinical trials within 3 months before screening
- Systolic Blood Pressure(SBP) 180 mmHg, Diastolic Blood Pressure(DBP) 110 mmHg or more
- Menopausal woman
- Laboratory test by show the following results
- Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
- Serum Creatinine > 2.0 mg/dL
- Pregnancy or breast feeding
- Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
- Principal Investigator judged inappropriate for participation in study because of 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 Soybean Germ Extract on Decrease of Body Fat
This study was conducted to investigate the effects of daily supplementation of Soybean germ extract on decrease of body fat
Read the detailed description
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. 80 subjects were randomly divided into Soybean germ extract 1,600 mg or placebo group. The investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and body mass index, etc.
- Conditions
- Obesity
- Being tested
- Soybean Germ Extract, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soybean Germ ExtractDietary supplement
Soybean Germ Extract 1,600 mg/day for 12 weeks.
PlaceboDietary supplement
Placebo 1,600 mg/day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Soybean Germ Extract | Experimental | Soybean Germ Extract 1,600 mg/day for 12 weeks. Receives: Dietary Supplement: Soybean Germ Extract |
| Placebo | Placebo comparator | Placebo 1,600 mg/day 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 (9)
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 report percent body fat in %.
Measured: Baseline 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 report fat free mass in g.
Measured: Baseline and 12 week
Changes of Anthropometric indicate: body weight
Anthropometric indices were measured in study screening, baseline and 12 week. Body weight in kg.
Measured: Screening, baseline and 12 week
Changes of Anthropometric indicate: body mass index
Anthropometric indices were measured in study screening, baseline and 12 week. Weight/height^2 will be report body mass index in kg/m^2.
Measured: Screening, baseline and 12 week
Changes of Anthropometric indices: waist circumference, hip circumference
Anthropometric indices were measured in study screening, baseline and 12 week. Waist circumference, hip circumference in cm.
Measured: Screening, baseline and 12 week
Changes of Anthropometric indicate: waist -hip circumference ratio
Anthropometric indices were measured in study screening, baseline and 12 week. Waist circumference/hip circumference will be report waist -hip circumference ratio.
Measured: Screening, baseline and 12 week
Changes of lipid metabolism indicators: Total cholesterol, Triglyceride, LDL-cholesterol, HDL-cholesterol
Lipid metabolism indicators(mg/dL) were measured in study baseline and 12 week.
Measured: Baseline and 12 week
Changes of obesity-related hormones indicators: Adiponectin, Leptin
obesity-related hormones indicators were measured in study baseline and 12 week
Measured: Baseline and 12 week
Changes of energy expenditure Indicators: Uncoupling protein-1(UCP-1), Peroxisome proliferator-activated receptor gamma coactivator-1 α(PGC-1 α)
energy expenditure Indicators were 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 posted1 Feb 2019
- Study start3 Jun 2019
- Primary completion28 Feb 2020 (estimated)
- Study completion28 Feb 2020 (estimated)
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 (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
- NCT03826212
- Sponsor's protocol ID
- NOVA-BF-SBG
- Status last verified
- Jul 2019
- First submitted
- 23 Jan 2019
- Last updated
- 24 Jul 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 24 Jul 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 Soybean Germ Extract on Decrease of Body Fat
- ClinicalTrials.gov ID
- NCT03826212
- Acronym / sponsor ID
- NOVA-BF-SBG
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 1 Feb 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 Soybean germ extract on decrease of body fat
Detailed description
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. 80 subjects were randomly divided into Soybean germ extract 1,600 mg or placebo group. The investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and body mass index, etc.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soybean Germ Extract | Experimental | Dietary Supplement: Soybean Germ ExtractSoybean Germ Extract 1,600 mg/day for 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo 1,600 mg/day 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/m^2
- After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice
Key exclusion criteria (16 listed)
- Those who lost more than 10% of their weight within 3 months before the screening
- Those who take a product(body fat improvement health functional foods, birth control pills, steroids, female hormone) that affects your weight within 4 weeks prior to the screening
- Those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
- Diabetic patients taking oral hypoglycemic agents or insulin (based on screening subjects)
- A person with a history of clinically significant hypersensitivity to soybeans
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 |
|---|---|---|
| Soybean Germ ExtractSoybean Germ Extract 1,600 mg/day for 12 weeks. | Dietary supplement | Soybean Germ Extract |
| PlaceboPlacebo 1,600 mg/day 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
9 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 Anthropometric indicate: body weight
Time frame: Screening, baseline and 12 week
Changes of Anthropometric indicate: body mass index
Time frame: Screening, baseline and 12 week
Changes of Anthropometric indices: waist circumference, hip circumference
Time frame: Screening, baseline and 12 week
Changes of Anthropometric indicate: waist -hip circumference ratio
Time frame: Screening, baseline and 12 week
Changes of lipid metabolism indicators: Total cholesterol, Triglyceride, LDL-cholesterol, HDL-cholesterol
Time frame: Baseline and 12 week
Changes of obesity-related hormones indicators: Adiponectin, Leptin
Time frame: Baseline and 12 week
Changes of energy expenditure Indicators: Uncoupling protein-1(UCP-1), Peroxisome proliferator-activated receptor gamma coactivator-1 α(PGC-1 α)
Time frame: Baseline 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 24 Jul 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 Soybean Germ Extract 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 16 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 24 Jul 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: 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 24 Jul 2019.