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

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ClinicalTrials.gov Identifier: NCT03645382
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Jong Ho Lee, Yonsei University

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.

Condition or disease Intervention/treatment Phase
Overweight Diabetes Mellitus Obesity Dietary Supplement: baked barley powder Dietary Supplement: jeju steam onion Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Jeju Steaming Onion(Oniro) on Reducing Body Fat of Overweight or Obesity Subjects
Actual Study Start Date : February 21, 2017
Actual Primary Completion Date : January 24, 2018
Actual Study Completion Date : January 24, 2018

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645382


Locations
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Korea, Republic of
Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jong Ho Lee, Professor, PI, Yonsei University
ClinicalTrials.gov Identifier: NCT03645382     History of Changes
Other Study ID Numbers: KO_Oniro_body fat
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jong Ho Lee, Yonsei University:
overweight
body fat
diabetic,
obersity
diabetes mellitus
DM
glycemic
Additional relevant MeSH terms:
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Diabetes Mellitus
Obesity
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms