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

Not Applicable

Completed

• Conditions: Obesity; Overweight; Diabetes Mellitus
• Interventions: Dietary Supplement: jeju steam onion; Dietary Supplement: baked barley powder

• Registration Number: NCT03645382
• Lead Sponsor: Yonsei University

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).

Study Timeline

• Study Start: 2017-02-21
• Primary Completion: 2018-01-24
• Study Completion: 2018-01-24
• Status Verified: 2018-08
• Study First Submitted: 2018-08-16
• Study First Submitted QC: 2018-08-22
• Last Update Submitted: 2018-08-22
• Study First Posted: 2018-08-24
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

overweight(WHO) subjects [25.0 kg/㎡ ≤ body mass index (BMI) < 30 kg/㎡]

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
jeju steam onion powder consumption	jeju steam onion	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.
baked barley powder consumption	baked barley powder	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline fat mass at 12-week.	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

Secondary Outcome Measures

Name	Time	Method
Change from baseline lean body mass at 12-week.	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
Change from baseline fat percentage at 12-week.	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
Change from baseline subcutaneous fat area of L1 and L4 at 12-week.	at baseline and 12-week follow-up	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.	at baseline and 12-week follow-up	The abdominal fat distribution was measured at L1 and L4 by computed tomography (CT)
Change from baseline whole fat area of L1 and L4 at 12-week.	at baseline and 12-week follow-up	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.	at baseline and 12-week follow-up	The abdominal fat distribution was measured at L1 and L4 by computed tomography (CT)

Trial Locations

Locations (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.; 🇰🇷 Seoul, Korea, Republic of