Diabetes Mellitus, Obesity, Overweight
Conditions
Keywords
overweight, body fat, diabetic,, obersity, diabetes mellitus, DM, glycemic
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.
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).
Interventions
DIETARY_SUPPLEMENTbaked 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.
DIETARY_SUPPLEMENTjeju 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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline fat mass at 12-week. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline lean body mass at 12-week. | 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 |
| Change from baseline fat percentage at 12-week. | 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 |
| Change from baseline whole fat area of L1 and L4 at 12-week. | at baseline and 12-week follow-up | The abdominal fat distribution was measured at L1 and L4 by computed tomography (CT) |
| Change from baseline visceral fat area of L1 and L4 at 12-week. | at baseline and 12-week follow-up | The abdominal fat distribution was measured at L1 and L4 by computed tomography (CT) |
| Change from baseline subcutaneous fat area of L1 and L4 at 12-week. | at baseline and 12-week follow-up | The abdominal fat distribution was measured at L1 and L4 by computed tomography (CT) |
| Change from baseline visceral/subcutaneous fat area ratio of L1 and L4 at 12-week. | at baseline and 12-week follow-up | The abdominal fat distribution was measured at L1 and L4 by computed tomography (CT) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline height(cm) at 12-week. | at baseline and 12-week follow-up | Briefly, all data were acquired at baseline and week 12. height(cm) was measured. |
| Change from baseline waist circumference(cm) at 12-week. | at baseline and 12-week follow-up | Briefly, all data were acquired at baseline and week 12. waist circumference(cm) was measured. |
| Change from baseline blood pressure (BP; mmHg) at 12-week. | at baseline and 12-week follow-up | Briefly, all data were acquired at baseline and week 12. blood pressure (BP; mmHg) was measured. |
| Change from baseline body mass index at 12-week. | 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/㎡). |
| Change from baseline weight at 12-week. | 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. |
Countries
South Korea
Outcome results
None listed