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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03645382
• Other study ID #: KO_Oniro_body fat
• Status: Completed
• Phase: N/A
• Start date: February 21, 2017
• Est. completion date: January 24, 2018

Study information

• Verified date: August 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 24, 2018
• Est. primary completion date: January 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity
• Overweight

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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