Efficacy and Safety of Extract of Gelidium Elegans
Double Blind, Randomized Controlled Study to Evaluate the Efficacy and Safety of Extract of Gelidium Elegans
1 other identifier
interventional
94
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Nov 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2018
CompletedFirst Submitted
Initial submission to the registry
February 6, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedFebruary 15, 2019
February 1, 2019
6 months
February 6, 2019
February 13, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (22)
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
- +17 more secondary outcomes
Study Arms (2)
Test group
EXPERIMENTALtaken 3 tablets of Gelidium elegans extract (1000 mg/day) once a day for 12 weeks
Control group
PLACEBO COMPARATORtaken 3 tablets of placebo once a day for 12 weeks
Interventions
Exract of Gelidium elegans will be given to the test group.
Eligibility Criteria
You may qualify if:
- \. Between the ages of 19 and 50
- \. BMI is at or greater than 23 and less than 30 kg/m\^2
You may not qualify if:
- \. uncontrolled hypertension
- \. uncontrolled diabetes
- \. current serious cerebrovascular and cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Family Medicine, Severance Hospital, College of Medicine, Yonsei University
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2019
First Posted
February 15, 2019
Study Start
November 8, 2017
Primary Completion
May 17, 2018
Study Completion
November 23, 2018
Last Updated
February 15, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share