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Efficacy and Safety of Extract of Gelidium Elegans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Exract of Gelidium elegans Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Double Blind, Randomized Controlled Study to Evaluate the Efficacy and Safety of Extract of Gelidium Elegans
Actual Study Start Date : November 8, 2017
Actual Primary Completion Date : May 17, 2018
Actual Study Completion Date : November 23, 2018

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.




Primary Outcome Measures :
  1. change in body fat mass by DEXA after 12-week treatment [ Time Frame: 12 week ]
  2. 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 ]

Secondary Outcome Measures :
  1. change in body weight and body fat mass will be combined to report by Bio-impedance [ Time Frame: 6 week ]
  2. change in body weight and body fat mass will be combined to report by Bio-impedance [ Time Frame: 12 week ]
  3. change in waist circumference [ Time Frame: 6 week ]
  4. change in waist circumference [ Time Frame: 12 week ]
  5. change in hip circumference [ Time Frame: 6 week ]
  6. change in hip circumference [ Time Frame: 12 week ]
  7. change in ratio of waist and hip circumference [ Time Frame: 6 week ]
  8. change in ratio of waist and hip circumference [ Time Frame: 12 week ]
  9. body mass index [ Time Frame: 6 week ]
  10. body mass index [ Time Frame: 12 week ]
  11. change in lean body mass by DEXA [ Time Frame: 6 week ]
  12. change in lean body mass by DEXA [ Time Frame: 12 week ]
  13. change in laboratory test result of total cholesterol, HDL, LDL and triglyceride will be combined to report as lipid profile [ Time Frame: 6 week ]
  14. change in laboratory test result of total cholesterol, HDL, LDL and triglyceride will be combined to report as lipid profile [ Time Frame: 12 week ]
  15. change in laboratory test result of CRP [ Time Frame: 6 week ]
  16. change in laboratory test result of CRP [ Time Frame: 12 week ]
  17. change in laboratory test result of fasting insulin [ Time Frame: 6 week ]
  18. change in laboratory test result of fasting insulin [ Time Frame: 12 week ]
  19. change in HOMA-IR [ Time Frame: 6 week ]
  20. change in HOMA-IR [ Time Frame: 12 week ]
  21. change in HOMA-beta [ Time Frame: 6 week ]
  22. change in HOMA-beta [ Time Frame: 12 week ]


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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03842774


Locations
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Korea, Republic of
Department of Family Medicine, Severance Hospital, College of Medicine, Yonsei University
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03842774     History of Changes
Other Study ID Numbers: 4-2017-0860
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No