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Completed

NCT Number: NCT03842774

Efficacy and Safety of Extract of Gelidium Elegans

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Family Medicine, Severance Hospital, College of Medicine, Yonsei University

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exract of Gelidium elegans

Dietary Supplement

Exract of Gelidium elegans will be given to the test group.

Placebo

Dietary Supplement

Placebo supplement will be given to the test group.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 15, 2019
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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