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Efficacy and Safety of Fermented Cinnamon Vine Powder on Decrement of Body Fat

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Soo-Wan Chae, Chonbuk National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01734187
First Posted: November 27, 2012
Last Update Posted: November 28, 2012
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.
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
  Purpose
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Fermented Cinnamon Vine Powde on decrement of body fat. The investigators measured decrement of body fat parameters , including abdominal fat, Body Fat Mass, LDL-C, HDL-C, Total Cholesterol and triglyceride, and monitored their blood pressure.

Condition Intervention Phase
Obesity Dietary Supplement: Fermented Cinnamon Vine Powder Dietary Supplement: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention

Further study details as provided by Soo-Wan Chae, Chonbuk National University Hospital:

Primary Outcome Measures:
  • Changes in abdominal Fat [ Time Frame: 12 weeks ]
    Abdominal Fat was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in Body Fat Mass [ Time Frame: 12 weeks ]
    Body Fat Mass was measured in study visit 1(0 week) and visit 3(12 week).


Secondary Outcome Measures:
  • Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol) [ Time Frame: 12 weeks ]
    LDL-C(Low Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol) [ Time Frame: 12 weeks ]
    HDL-cholesterol(High Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in total cholesterol [ Time Frame: 12 weeks ]
    Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in Triglycerides [ Time Frame: 12 weeks ]
    Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).


Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: November 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fermented Cinnamon Vine Powder Dietary Supplement: Fermented Cinnamon Vine Powder
Fermented Cinnamon Vine Powder (30g/day)
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo (30g/day)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females 19-55 years old
  • BMI(body mass index) ≥ 25 kg/m^2 or WC(Waist Circumference) ≥ 90(men), WC ≥ 85(women)
  • Able to give informed consent

Exclusion Criteria:

  • Significant variation in weight(more 10%) in the past 3 months
  • Allergic or hypersensitive to any of the ingredients in the test products
  • History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
  • History of alcohol or substance abuse
  • Participation in any other clinical trials within past 2 months
  • Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
  • Pregnant or lactating women etc.
  Contacts and Locations
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): NCT01734187


Locations
Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital Recruiting
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Contact: Soo-Wan Chae, MD., PhD    82-63-250-2539    soowan@jbnu.ac.kr   
Sponsors and Collaborators
Chonbuk National University Hospital
  More Information

Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01734187     History of Changes
Other Study ID Numbers: CHEVIGEN-OBESE-DB
First Submitted: November 22, 2012
First Posted: November 27, 2012
Last Update Posted: November 28, 2012
Last Verified: November 2012