Efficacy and Safety of Extract of Gelidium Elegans

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Exract of Gelidium elegans; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Department of Family Medicine, Severance Hospital, College of Medicine, Yonsei University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2017
• Primary Completion (Actual): May 17, 2018
• Study Completion (Actual): November 23, 2018

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 4-2017-0860

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No