Efficacy and Safety of Extract of Gelidium Elegans

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03842774
• Other study ID #: 4-2017-0860
• Status: Completed
• Phase: N/A
• Start date: November 8, 2017
• Est. completion date: November 23, 2018

Study information

• Verified date: February 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: November 23, 2018
• Est. primary completion date: May 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Exract of Gelidium elegans
Exract of Gelidium elegans will be given to the test group.
• Placebo
Placebo supplement will be given to the test group.

Locations

Country	Name	City	State
Korea, Republic of	Department of Family Medicine, Severance Hospital, College of Medicine, Yonsei University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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