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

NCT03645382 | Completed

• 1 other identifier: KO_Oniro_body fat
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Diabetes Mellitus; Obesity

Keywords

overweight; body fat; diabetic,; obersity; diabetes mellitus; DM; glycemic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change from baseline fat percentage at 12-week.

  at baseline and 12-week follow-up

• Change from baseline lean body mass at 12-week.

  at baseline and 12-week follow-up

• Change from baseline whole fat area of L1 and L4 at 12-week.

  at baseline and 12-week follow-up

• Change from baseline visceral fat area of L1 and L4 at 12-week.

  at baseline and 12-week follow-up

• Change from baseline subcutaneous fat area of L1 and L4 at 12-week.

  at baseline and 12-week follow-up

Other Outcomes (5)

• Change from baseline weight at 12-week.

  at baseline and 12-week follow-up

• Change from baseline body mass index at 12-week.

  at baseline and 12-week follow-up

• Change from baseline height(cm) at 12-week.

  at baseline and 12-week follow-up

Study Arms (2)

baked barley powder consumption

PLACEBO COMPARATOR

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

jeju steam onion powder consumption

EXPERIMENTAL

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

Interventions

baked barley powder 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.

baked barley powder consumption

jeju steam onion 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.

jeju steam onion powder consumption

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Seoul, 03722, South Korea

Location

Related Publications (1)

• 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.

  PMID: 31368861 DERIVED

MeSH Terms

Conditions

Overweight; Diabetes Mellitus; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PI

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 24, 2018
• Study Start: February 21, 2017
• Primary Completion: January 24, 2018
• Study Completion: January 24, 2018
• Last Updated: August 24, 2018

Record last verified: 2018-08

Locations

KR (1)