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

NCT ID: NCT03645382

Last Updated: 2018-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-21

Study Completion Date

2018-01-24

Brief Summary

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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

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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).

Conditions

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Overweight Diabetes Mellitus Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

baked barley powder

Intervention Type DIETARY_SUPPLEMENT

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 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.

Group Type EXPERIMENTAL

jeju steam onion

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Jong Ho Lee

Professor, PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 31368861 (View on PubMed)

Other Identifiers

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KO_Oniro_body fat

Identifier Type: -

Identifier Source: org_study_id

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