Efficacy and Safety of Extract of Gelidium Elegans

Study Overview
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Brief Summary
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Extract of Gelidium elegans inhibits lipid differentiation, accumulation, and synthesis in vitro and in vivo. It has also anti-obesity effect by inhibiting weight gain and decreasing body fat. In a preliminary study of obese adults aged 20 years or older, the extracts of Gelidium elegans showed a tendency to decrease in body fat and visceral fat, and to increase lean body mass. Based on these results, we tried to confirm the effect of body weight and body fat reduction of Gelidium elegans extract in overweight and obese people.

Official Title
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Double Blind, Randomized Controlled Study to Evaluate the Efficacy and Safety of Extract of Gelidium Elegans

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Exract of Gelidium elegans
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Between the ages of 19 and 50 2. BMI is at or greater than 23 and less than 30 kg/m^2 Exclusion Criteria: 1. uncontrolled hypertension 2. uncontrolled diabetes 3. current serious cerebrovascular and cardiovascular disease

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>taken 3 tablets of Gelidium elegans extract (1000 mg/day) once a day for 12 weeks | Dietary Supplement: Exract of Gelidium elegans<br>* Exract of Gelidium elegans will be given to the test group.<br>|
| Placebo Comparator: Control group<br>taken 3 tablets of placebo once a day for 12 weeks | Dietary Supplement: Placebo<br>* Placebo supplement will be given to the test group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in body fat mass by DEXA after 12-week treatment |  | 12 week | 
| change in visceral, subcutaneous, total fat area and ratio of visceral and subcutaneous fat area will be combined to report by Fat CT after 12-week treatment |  | 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in body weight and body fat mass will be combined to report by Bio-impedance |  | 6 week | 
| change in body weight and body fat mass will be combined to report by Bio-impedance |  | 12 week | 
| change in waist circumference |  | 6 week | 
| change in waist circumference |  | 12 week | 
| change in hip circumference |  | 6 week | 
| change in hip circumference |  | 12 week | 
| change in ratio of waist and hip circumference |  | 6 week | 
| change in ratio of waist and hip circumference |  | 12 week | 
| body mass index |  | 6 week | 
| body mass index |  | 12 week | 
| change in lean body mass by DEXA |  | 6 week | 
| change in lean body mass by DEXA |  | 12 week | 
| change in laboratory test result of total cholesterol, HDL, LDL and triglyceride will be combined to report as lipid profile |  | 6 week | 
| change in laboratory test result of total cholesterol, HDL, LDL and triglyceride will be combined to report as lipid profile |  | 12 week | 
| change in laboratory test result of CRP |  | 6 week | 
| change in laboratory test result of CRP |  | 12 week | 
| change in laboratory test result of fasting insulin |  | 6 week | 
| change in laboratory test result of fasting insulin |  | 12 week | 
| change in HOMA-IR |  | 6 week | 
| change in HOMA-IR |  | 12 week | 
| change in HOMA-beta |  | 6 week | 
| change in HOMA-beta |  | 12 week |