The Effects of Jeju Steaming Onion(Oniro) on Reducing Body Fat of Overweight or Obesity Subjects

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Effects of Jeju Steaming Onion(Oniro) on Reducing Body Fat of Overweight or Obesity Subjects

Conditions
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Overweight, Diabetes Mellitus, Obesity

Intervention / Treatment
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* Dietary Supplement: baked barley powder
* Dietary Supplement: jeju steam onion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: overweight(WHO) subjects [25.0 kg/㎡ ≤ body mass index (BMI) < 30 kg/㎡] Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: baked barley powder consumption<br>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. | Dietary Supplement: baked barley powder<br>* 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.<br>|
| Experimental: jeju steam onion powder consumption<br>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. | Dietary Supplement: jeju steam onion<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at baseline and 12-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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) | 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) | 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) | 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) | at baseline and 12-week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight, body fat, diabetic,, obersity, diabetes mellitus, DM, glycemic