Clinical trial NCT03842774: Efficacy and Safety of Extract of Gelidium Elegans
Official title: Double Blind, Randomized Controlled Study to Evaluate the Efficacy and Safety of Extract of Gelidium Elegans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 94
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: change in body fat mass by DEXA after 12-week treatment
timeFrame: 12 week
measure: 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
timeFrame: 12 week
Secondary outcomes:
measure: change in body weight and body fat mass will be combined to report by Bio-impedance
timeFrame: 6 week
measure: change in body weight and body fat mass will be combined to report by Bio-impedance
timeFrame: 12 week
measure: change in waist circumference
timeFrame: 6 week
measure: change in waist circumference
timeFrame: 12 week
measure: change in hip circumference
timeFrame: 6 week
measure: change in hip circumference
timeFrame: 12 week
measure: change in ratio of waist and hip circumference
timeFrame: 6 week
measure: change in ratio of waist and hip circumference
timeFrame: 12 week
measure: body mass index
timeFrame: 6 week
measure: body mass index
timeFrame: 12 week
measure: change in lean body mass by DEXA
timeFrame: 6 week
measure: change in lean body mass by DEXA
timeFrame: 12 week
measure: change in laboratory test result of total cholesterol, HDL, LDL and triglyceride will be combined to report as lipid profile
timeFrame: 6 week
measure: change in laboratory test result of total cholesterol, HDL, LDL and triglyceride will be combined to report as lipid profile
timeFrame: 12 week
measure: change in laboratory test result of CRP
timeFrame: 6 week
measure: change in laboratory test result of CRP
timeFrame: 12 week
measure: change in laboratory test result of fasting insulin
timeFrame: 6 week
measure: change in laboratory test result of fasting insulin
timeFrame: 12 week
measure: change in HOMA-IR
timeFrame: 6 week
measure: change in HOMA-IR
timeFrame: 12 week
measure: change in HOMA-beta
timeFrame: 6 week
measure: change in HOMA-beta
timeFrame: 12 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Family Medicine, Severance Hospital, College of Medicine, Yonsei University
Study officials:
References: