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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Fermented Cinnamon Vine Powder; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
      • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo (30g/day)
Experimental: Fermented Cinnamon Vine Powder	Dietary supplement: Fermented Cinnamon Vine Powder; Fermented Cinnamon Vine Powder (30g/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Body Fat Mass	Body Fat Mass was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks
Changes in abdominal Fat	Abdominal Fat was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol)	LDL-C(Low Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks
Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol)	HDL-cholesterol(High Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks
Changes in Triglycerides	Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks
Changes in total cholesterol	Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2012
• Primary Completion (Actual): May 29, 2014
• Study Completion (Actual): May 29, 2014

Study Registration Dates

• First Submitted: November 22, 2012
• First Submitted That Met QC Criteria: November 22, 2012
• First Posted (Estimate): November 27, 2012

Study Record Updates

• Last Update Posted (Actual): September 3, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CHEVIGEN-OBESE-DB