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Efficacy and Safety of Extract of Gelidium Elegans

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ClinicalTrials.gov Identifier: NCT03842774
Recruitment Status : Completed
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE February 6, 2019
First Posted Date  ICMJE February 15, 2019
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE November 8, 2017
Actual Primary Completion Date May 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
  • change in body fat mass by DEXA after 12-week treatment [ Time Frame: 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 [ Time Frame: 12 week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
  • change in body weight and body fat mass will be combined to report by Bio-impedance [ Time Frame: 6 week ]
  • change in body weight and body fat mass will be combined to report by Bio-impedance [ Time Frame: 12 week ]
  • change in waist circumference [ Time Frame: 6 week ]
  • change in waist circumference [ Time Frame: 12 week ]
  • change in hip circumference [ Time Frame: 6 week ]
  • change in hip circumference [ Time Frame: 12 week ]
  • change in ratio of waist and hip circumference [ Time Frame: 6 week ]
  • change in ratio of waist and hip circumference [ Time Frame: 12 week ]
  • body mass index [ Time Frame: 6 week ]
  • body mass index [ Time Frame: 12 week ]
  • change in lean body mass by DEXA [ Time Frame: 6 week ]
  • change in lean body mass by DEXA [ Time Frame: 12 week ]
  • change in laboratory test result of total cholesterol, HDL, LDL and triglyceride will be combined to report as lipid profile [ Time Frame: 6 week ]
  • change in laboratory test result of total cholesterol, HDL, LDL and triglyceride will be combined to report as lipid profile [ Time Frame: 12 week ]
  • change in laboratory test result of CRP [ Time Frame: 6 week ]
  • change in laboratory test result of CRP [ Time Frame: 12 week ]
  • change in laboratory test result of fasting insulin [ Time Frame: 6 week ]
  • change in laboratory test result of fasting insulin [ Time Frame: 12 week ]
  • change in HOMA-IR [ Time Frame: 6 week ]
  • change in HOMA-IR [ Time Frame: 12 week ]
  • change in HOMA-beta [ Time Frame: 6 week ]
  • change in HOMA-beta [ Time Frame: 12 week ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Extract of Gelidium Elegans
Official Title  ICMJE Double Blind, Randomized Controlled Study to Evaluate the Efficacy and Safety of Extract of Gelidium Elegans
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE
  • Dietary Supplement: Exract of Gelidium elegans
    Exract of Gelidium elegans will be given to the test group.
  • Dietary Supplement: Placebo
    Placebo supplement will be given to the test group.
Study Arms  ICMJE
  • Experimental: Test group
    taken 3 tablets of Gelidium elegans extract (1000 mg/day) once a day for 12 weeks
    Intervention: Dietary Supplement: Exract of Gelidium elegans
  • Placebo Comparator: Control group
    taken 3 tablets of placebo once a day for 12 weeks
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2019)
94
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 23, 2018
Actual Primary Completion Date May 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03842774
Other Study ID Numbers  ICMJE 4-2017-0860
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP