Clinical trial NCT03645382: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Diabetes Mellitus
Obesity
Keywords: overweight
body fat
diabetic,
obersity
diabetes mellitus
DM
glycemic
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change from baseline fat mass at 12-week.
timeFrame: at baseline and 12-week follow-up
Secondary outcomes:
measure: Change from baseline fat percentage at 12-week.
timeFrame: at baseline and 12-week follow-up
measure: Change from baseline lean body mass at 12-week.
timeFrame: at baseline and 12-week follow-up
measure: Change from baseline whole fat area of L1 and L4 at 12-week.
timeFrame: at baseline and 12-week follow-up
measure: Change from baseline visceral fat area of L1 and L4 at 12-week.
timeFrame: at baseline and 12-week follow-up
measure: Change from baseline subcutaneous fat area of L1 and L4 at 12-week.
timeFrame: at baseline and 12-week follow-up
measure: Change from baseline visceral/subcutaneous fat area ratio of L1 and L4 at 12-week.
timeFrame: at baseline and 12-week follow-up
Other outcomes:
measure: Change from baseline weight at 12-week.
timeFrame: at baseline and 12-week follow-up
measure: Change from baseline body mass index at 12-week.
timeFrame: at baseline and 12-week follow-up
measure: Change from baseline height(cm) at 12-week.
timeFrame: at baseline and 12-week follow-up
measure: Change from baseline waist circumference(cm) at 12-week.
timeFrame: at baseline and 12-week follow-up
measure: Change from baseline blood pressure (BP; mmHg) at 12-week.
timeFrame: at baseline and 12-week follow-up
Locations:
city: Seoul
country: Korea, Republic of
facility: Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Study officials:
References:
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.