Efficacy and Safety of Extract of Gelidium Elegans

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Exract of Gelidium elegans; Dietary Supplement: Placebo

• Registration Number: NCT03842774
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-08
• Primary Completion: 2018-05-17
• Study Completion: 2018-11-23
• Status Verified: 2019-02
• Study First Submitted: 2019-02-06
• Study First Submitted QC: 2019-02-13
• Last Update Submitted: 2019-02-13
• Study First Posted: 2019-02-15
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Exract of Gelidium elegans	taken 3 tablets of Gelidium elegans extract (1000 mg/day) once a day for 12 weeks
Control group	Placebo	taken 3 tablets of placebo once a day for 12 weeks

Primary Outcome Measures

Name	Time	Method
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
change in body fat mass by DEXA after 12-week treatment	12 week

Secondary Outcome Measures

Name	Time	Method
change in body weight and body fat mass will be combined to report by Bio-impedance	12 week
change in laboratory test result of fasting insulin	12 week
change in ratio of waist and hip circumference	12 week
body mass index	12 week
change in lean body mass by DEXA	12 week
change in waist circumference	12 week
change in laboratory test result of CRP	12 week
change in hip circumference	12 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 HOMA-IR	12 week
change in HOMA-beta	12 week

Trial Locations

Locations (1)

Department of Family Medicine, Severance Hospital, College of Medicine, Yonsei University; 🇰🇷 Seoul, Korea, Republic of