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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus; Overweight
• Intervention / Treatment: Dietary supplement: baked barley powder; Dietary supplement: jeju steam onion

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: baked barley powder consumption; 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; 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.
Experimental: jeju steam onion powder consumption; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline weight at 12-week.	Briefly, all data were acquired at baseline and week 12. body weight (kg; Inbody370, Biospace Co., Ltd Korea) was measured.	at baseline and 12-week follow-up
Change from baseline body mass index at 12-week.	Briefly, all data were acquired at baseline and week 12. BMI was calculated in units of kilogram per square meter (kg/㎡).	at baseline and 12-week follow-up
Change from baseline height(cm) at 12-week.	Briefly, all data were acquired at baseline and week 12. height(cm) was measured.	at baseline and 12-week follow-up
Change from baseline waist circumference(cm) at 12-week.	Briefly, all data were acquired at baseline and week 12. waist circumference(cm) was measured.	at baseline and 12-week follow-up
Change from baseline blood pressure (BP; mmHg) at 12-week.	Briefly, all data were acquired at baseline and week 12. blood pressure (BP; mmHg) was measured.	at baseline and 12-week follow-up

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2017
• Primary Completion (Actual): January 24, 2018
• Study Completion (Actual): January 24, 2018

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: overweight; diabetes mellitus; DM; body fat; diabetic,; obersity; glycemic
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Diabetes Mellitus; Obesity; Overweight
• Other Study ID Numbers: KO_Oniro_body fat

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No