Efficacy and Safety of Fermented Cinnamon Vine Powder on... | NCT01734187

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

NCT01734187

Sponsor

Chonbuk National University Hospital

Status

Completed

Last Update Posted

Sep 3, 2019Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Fermented Cinnamon Vine Powder
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2012Actual

Primary Completion Date

May 29, 2014Actual

Completion Date

May 29, 2014Actual

First Submitted Date

Nov 22, 2012

First Submission Date that Met QC Criteria

Nov 22, 2012

First Posted Date

Nov 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2019

Last Update Posted Date

Sep 3, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University HospitalPrincipal Investigator

Lead Sponsor

Chonbuk National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fermented Cinnamon Vine Powder	Experimental		Dietary Supplement: Fermented Cinnamon Vine Powder
Placebo	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fermented Cinnamon Vine Powder	Dietary Supplement	Fermented Cinnamon Vine Powder (30g/day)	Fermented Cinnamon Vine Powder

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital		Jeonju	Jeollabuk-do	560-822	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

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Browse Branches

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