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Completed

NCT Number: NCT03645382

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.

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Key information

Conditions

Overweight Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Seoul, 03722, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change from baseline fat mass at 12-week.

    Time frame: 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 outcomes

  1. Change from baseline fat percentage at 12-week.

    Time frame: 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

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

    Time frame: 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

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

    Time frame: at baseline and 12-week follow-up

    The abdominal fat distribution was measured at L1 and L4 by computed tomography (CT)

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

    Time frame: at baseline and 12-week follow-up

    The abdominal fat distribution was measured at L1 and L4 by computed tomography (CT)

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

    Time frame: at baseline and 12-week follow-up

    The abdominal fat distribution was measured at L1 and L4 by computed tomography (CT)

  6. Change from baseline visceral/subcutaneous fat area ratio of L1 and L4 at 12-week.

    Time frame: at baseline and 12-week follow-up

    The abdominal fat distribution was measured at L1 and L4 by computed tomography (CT)

Other outcomes

  1. Change from baseline weight at 12-week.

    Time frame: at baseline and 12-week follow-up

    Briefly, all data were acquired at baseline and week 12. body weight (kg; Inbody370, Biospace Co., Ltd Korea) was measured.

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

    Time frame: at baseline and 12-week follow-up

    Briefly, all data were acquired at baseline and week 12. BMI was calculated in units of kilogram per square meter (kg/㎡).

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

    Time frame: at baseline and 12-week follow-up

    Briefly, all data were acquired at baseline and week 12. height(cm) was measured.

  4. Change from baseline waist circumference(cm) at 12-week.

    Time frame: at baseline and 12-week follow-up

    Briefly, all data were acquired at baseline and week 12. waist circumference(cm) was measured.

  5. Change from baseline blood pressure (BP; mmHg) at 12-week.

    Time frame: at baseline and 12-week follow-up

    Briefly, all data were acquired at baseline and week 12. blood pressure (BP; mmHg) was measured.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 24, 2018
Registry last updated
Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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