OverweightNCT03645382
The Effects of Jeju Steaming Onion(Oniro) on Reducing Body Fat of Overweight or Obesity Subjects
A study testing baked barley powder and jeju steam onion in people with Overweight and Diabetes Mellitus, run by Yonsei University at 1 site in South Korea.
Trial summary
It is well known that steam onion have benefit effects on controlling the blood sugar, triacylglycerol (TG) and total cholesterol (TC). In this study, the jeju steam onion examined whether it has beneficial effects on reducing body fat of overweight or obesity subjects. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Diabetes Mellitus, Obesity
- What is being tested?
- baked barley powder and jeju steam onion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Feb 2017to 24 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- overweight(WHO) subjects [25.0 kg/㎡ ≤ body mass index (BMI) < 30 kg/㎡]
Who cannot join
- uncontrolled blood pressure (blood pressure level more than 140/100mmHg)
- fasting blood sugar level more than 126 mg/dl or taking medications (including blood sugar and anti-diabetic drugs)
- history of serious cardiovascular, pulmonary, gastrointestinal, hepatic, renal and/or haematological disease
- taking a weight change medications within 1 month before study
- participation other obese studies within 2 months before study
- having a known allergy to any ingredient in the investigational product
Show all 9Show fewer
- participation other intervention studies within 1 months before study
- women who are pregnant or desire to become pregnant during the study period
- having any other medical condition which, in the opinion of the investigator, could interfere with participation in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Seoul, 03722
About this study
It is well known that steam onion have benefit effects on controlling the blood sugar, triacylglycerol (TG) and total cholesterol (TC). In this study, the jeju steam onion examined whether it has beneficial effects on reducing body fat of overweight or obesity subjects.
Read the detailed description
A randomized, double-blind, placebo-controlled clinical trial was conducted to verify the effects of jeju steam onion. Fifty-six healthy male and female subjects aged 20-65 years with normal body weight [25.0 kg/㎡ ≤ body mass index (BMI) < 30.0 kg/㎡] were recruited. The basic framework of the present study was based on a previous study. A 12-week (at each visit; screening, 6-week, 12-week), placebo-controlled, randomized study was conducted with overweight subjects (25.0 kg/㎡ ≤ BMI < 30 kg/㎡). Subjects participants were divided into two group: either Jeju steaming onion or matching placebo (the baked barley powder). Randomization was achieved by computer generated block randomization (placebo : test = 1 : 1).
- Conditions
- Overweight, Diabetes Mellitus, Obesity
- Being tested
- baked barley powder, jeju steam onion
- Keywords
- overweight, body fat, diabetic,, obersity, diabetes mellitus, DM, glycemic
- Medical subject headings
- Overweight, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baked barley powderDietary supplement
The baked barley was consumed one capsules, three times daily before meals, for a total of three capsules consumed per day.The baked barley powder capsule had approximately 900 mg/day, 336 mg of baked barley and 564 mg of nondigestible maltodextrin.
jeju steam onionDietary supplement
The jeju steam onion was consumed one capsules, three times daily before meals, for a total of three capsules consumed per day.The jeju steam onion capsule had approximately 900 mg/day, 336 mg of jeju steam onion powder and 564 mg of nondigestible maltodextrin.
| Study group | Role | What they receive |
|---|---|---|
| baked barley powder consumption | Placebo comparator | Subjects randomized to the placebo group received one tablet containing baked barley powder per day (900 mg/day). placebo group consumed one capsules, three times daily before meals, for a total of three capsules consumed per day. Receives: Dietary Supplement: baked barley powder |
| jeju steam onion powder consumption | Experimental | Subjects randomized to the test group received one tablet containing jeju steam onion powder per day (900 mg/day). placebo group consumed one capsules, three times daily before meals, for a total of three capsules consumed per day. Receives: Dietary Supplement: jeju steam onion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline fat mass at 12-week.
The body composition of the study participants was measured via dual-energy X-ray absorptiometry (DEXA) to determine
Measured: at baseline and 12-week follow-up
Secondary outcomes (6)
Change from baseline fat percentage at 12-week.
The body composition of the study participants was measured via dual-energy X-ray absorptiometry (DEXA) to determine
Measured: at baseline and 12-week follow-up
Change from baseline lean body mass at 12-week.
The body composition of the study participants was measured via dual-energy X-ray absorptiometry (DEXA) to determine
Measured: at baseline and 12-week follow-up
Change from baseline whole fat area of L1 and L4 at 12-week.
The abdominal fat distribution was measured at L1 and L4 by computed tomography (CT)
Measured: at baseline and 12-week follow-up
Change from baseline visceral fat area of L1 and L4 at 12-week.
The abdominal fat distribution was measured at L1 and L4 by computed tomography (CT)
Measured: at baseline and 12-week follow-up
Change from baseline subcutaneous fat area of L1 and L4 at 12-week.
The abdominal fat distribution was measured at L1 and L4 by computed tomography (CT)
Measured: at baseline and 12-week follow-up
Change from baseline visceral/subcutaneous fat area ratio of L1 and L4 at 12-week.
The abdominal fat distribution was measured at L1 and L4 by computed tomography (CT)
Measured: at baseline and 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start21 Feb 2017
- Primary completion24 Jan 2018
- Study completion24 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Ho Lee, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645382
- Sponsor's protocol ID
- KO_Oniro_body fat
- Status last verified
- Aug 2018
- First submitted
- 16 Aug 2018
- Last updated
- 24 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jeong S, Chae J, Lee G, Shin G, Kwon YI, Oh JB, Shin DY, Lee JH. Effect of Steamed Onion (ONIRO) Consumption on Body Fat and Metabolic Profiles in Overweight Subjects: A 12-Week Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Am Coll Nutr. 2020 Mar-Apr;39(3):206-215. doi: 10.1080/07315724.2019.1635052. Epub 2019 Aug 1.
PubMed 31368861
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Jeju Steaming Onion(Oniro) on Reducing Body Fat of Overweight or Obesity Subjects
- ClinicalTrials.gov ID
- NCT03645382
- Acronym / sponsor ID
- KO_Oniro_body fat
- Conditions
- Overweight, Diabetes Mellitus, Obesity
- Keywords
- overweight, body fat, diabetic,, obersity, diabetes mellitus, DM, glycemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 24 Jan 2018 (actual)
- First posted
- 24 Aug 2018 (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.
It is well known that steam onion have benefit effects on controlling the blood sugar, triacylglycerol (TG) and total cholesterol (TC). In this study, the jeju steam onion examined whether it has beneficial effects on reducing body fat of overweight or obesity subjects.
Detailed description
A randomized, double-blind, placebo-controlled clinical trial was conducted to verify the effects of jeju steam onion. Fifty-six healthy male and female subjects aged 20-65 years with normal body weight [25.0 kg/㎡ ≤ body mass index (BMI) < 30.0 kg/㎡] were recruited. The basic framework of the present study was based on a previous study. A 12-week (at each visit; screening, 6-week, 12-week), placebo-controlled, randomized study was conducted with overweight subjects (25.0 kg/㎡ ≤ BMI < 30 kg/㎡). Subjects participants were divided into two group: either Jeju steaming onion or matching placebo (the baked barley powder). Randomization was achieved by computer generated block randomization (placebo : test = 1 : 1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| baked barley powder consumption | Placebo comparator | Dietary Supplement: baked barley powderSubjects randomized to the placebo group received one tablet containing baked barley powder per day (900 mg/day). placebo group consumed one capsules, three times daily before meals, for a total of three capsules consumed per day. |
| jeju steam onion powder consumption | Experimental | Dietary Supplement: jeju steam onionSubjects randomized to the test group received one tablet containing jeju steam onion powder per day (900 mg/day). placebo group consumed one capsules, three times daily before meals, for a total of three capsules consumed per day. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- overweight(WHO) subjects [25.0 kg/㎡ ≤ body mass index (BMI) < 30 kg/㎡]
Key exclusion criteria (9 listed)
- uncontrolled blood pressure (blood pressure level more than 140/100mmHg)
- fasting blood sugar level more than 126 mg/dl or taking medications (including blood sugar and anti-diabetic drugs)
- history of serious cardiovascular, pulmonary, gastrointestinal, hepatic, renal and/or haematological disease
- taking a weight change medications within 1 month before study
- participation other obese studies within 2 months before 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 |
|---|---|---|
| baked barley powderThe baked barley was consumed one capsules, three times daily before meals, for a total of three capsules consumed per day.The baked barley powder capsule had approximately 900 mg/day, 336 mg of baked barley and 564 mg of nondigestible maltodextrin. | Dietary supplement | baked barley powder consumption |
| jeju steam onionThe jeju steam onion was consumed one capsules, three times daily before meals, for a total of three capsules consumed per day.The jeju steam onion capsule had approximately 900 mg/day, 336 mg of jeju steam onion powder and 564 mg of nondigestible maltodextrin. | Dietary supplement | jeju steam onion powder consumption |
Primary outcome
Change from baseline fat mass at 12-week.
Time frame: at baseline and 12-week follow-up
The body composition of the study participants was measured via dual-energy X-ray absorptiometry (DEXA) to determine
6 secondary outcomes
Change from baseline fat percentage at 12-week.
Time frame: at baseline and 12-week follow-up
Change from baseline lean body mass at 12-week.
Time frame: at baseline and 12-week follow-up
Change from baseline whole fat area of L1 and L4 at 12-week.
Time frame: at baseline and 12-week follow-up
Change from baseline visceral fat area of L1 and L4 at 12-week.
Time frame: at baseline and 12-week follow-up
Change from baseline subcutaneous fat area of L1 and L4 at 12-week.
Time frame: at baseline and 12-week follow-up
Change from baseline visceral/subcutaneous fat area ratio of L1 and L4 at 12-week.
Time frame: at baseline and 12-week follow-up
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 24 Aug 2018.
- Derived from this study: PubMed 31368861Jeong S, Chae J, Lee G, Shin G, Kwon YI, Oh JB, Shin DY, Lee JH. Effect of Steamed Onion (ONIRO) Consumption on Body Fat and Metabolic Profiles in Overweight Subjects: A 12-Week Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Am Coll Nutr. 2020 Mar-Apr;39(3):206-215. doi: 10.1080/07315724.2019.1635052. Epub 2019 Aug 1.
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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 baked barley powder and jeju steam onion in people with Overweight and Diabetes Mellitus, run by Yonsei University 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 1 inclusion and 9 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 24 Aug 2018. 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?
Change from baseline fat mass at 12-week. (time frame: at baseline and 12-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03645382, which also lists 1 linked publication.
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 Aug 2018.