Back to resultsThe Effects of Jeju Steaming Onion(Oniro) on Reducing Body Fat of Overweight or Obesity Subjects
Primary Purpose
Overweight, Diabetes Mellitus, Obesity
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
baked barley powder
jeju steam onion
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring overweight, body fat, diabetic,, obersity, diabetes mellitus, DM, glycemic
Eligibility Criteria
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
Sites / Locations
- Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
baked barley powder consumption
jeju steam onion powder consumption
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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)
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)
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03645382
Brief Title
The Effects of Jeju Steaming Onion(Oniro) on Reducing Body Fat of Overweight or Obesity Subjects
Official Title
The Effects of Jeju Steaming Onion(Oniro) on Reducing Body Fat of Overweight or Obesity Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
January 24, 2018 (Actual)
Study Completion Date
January 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Diabetes Mellitus, Obesity
Keywords
overweight, body fat, diabetic,, obersity, diabetes mellitus, DM, glycemic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
baked barley powder consumption
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
jeju steam onion powder consumption
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
baked barley powder
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
jeju steam onion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline fat mass at 12-week.
Description
The body composition of the study participants was measured via dual-energy X-ray absorptiometry (DEXA) to determine
Time Frame
at baseline and 12-week follow-up
Secondary Outcome Measure Information:
Title
Change from baseline fat percentage at 12-week.
Description
The body composition of the study participants was measured via dual-energy X-ray absorptiometry (DEXA) to determine
Time Frame
at baseline and 12-week follow-up
Title
Change from baseline lean body mass at 12-week.
Description
The body composition of the study participants was measured via dual-energy X-ray absorptiometry (DEXA) to determine
Time Frame
at baseline and 12-week follow-up
Title
Change from baseline whole fat area of L1 and L4 at 12-week.
Description
The abdominal fat distribution was measured at L1 and L4 by computed tomography (CT)
Time Frame
at baseline and 12-week follow-up
Title
Change from baseline visceral fat area of L1 and L4 at 12-week.
Description
The abdominal fat distribution was measured at L1 and L4 by computed tomography (CT)
Time Frame
at baseline and 12-week follow-up
Title
Change from baseline subcutaneous fat area of L1 and L4 at 12-week.
Description
The abdominal fat distribution was measured at L1 and L4 by computed tomography (CT)
Time Frame
at baseline and 12-week follow-up
Title
Change from baseline visceral/subcutaneous fat area ratio of L1 and L4 at 12-week.
Description
The abdominal fat distribution was measured at L1 and L4 by computed tomography (CT)
Time Frame
at baseline and 12-week follow-up
Other Pre-specified Outcome Measures:
Title
Change from baseline weight at 12-week.
Description
Briefly, all data were acquired at baseline and week 12. body weight (kg; Inbody370, Biospace Co., Ltd Korea) was measured.
Time Frame
at baseline and 12-week follow-up
Title
Change from baseline body mass index at 12-week.
Description
Briefly, all data were acquired at baseline and week 12. BMI was calculated in units of kilogram per square meter (kg/㎡).
Time Frame
at baseline and 12-week follow-up
Title
Change from baseline height(cm) at 12-week.
Description
Briefly, all data were acquired at baseline and week 12. height(cm) was measured.
Time Frame
at baseline and 12-week follow-up
Title
Change from baseline waist circumference(cm) at 12-week.
Description
Briefly, all data were acquired at baseline and week 12. waist circumference(cm) was measured.
Time Frame
at baseline and 12-week follow-up
Title
Change from baseline blood pressure (BP; mmHg) at 12-week.
Description
Briefly, all data were acquired at baseline and week 12. blood pressure (BP; mmHg) was measured.
Time Frame
at baseline and 12-week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
31368861
Citation
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.
Results Reference
derived
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The Effects of Jeju Steaming Onion(Oniro) on Reducing Body Fat of Overweight or Obesity Subjects
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