Efficacy and Safety of Zingiber Officinale Roscoe Extract... | NCT03260751

Studies
Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat

NCT03260751

Sponsor

Chonbuk National University Hospital

Status

Completed

Last Update Posted

May 9, 2019Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Zingiber officinale Roscoe extract 200 mg
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

May 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

Feb 3, 2017Actual

Primary Completion Date

Jan 29, 2018Actual

Completion Date

Jan 29, 2018Actual

First Submitted Date

Aug 22, 2017

First Submission Date that Met QC Criteria

Aug 22, 2017

First Posted Date

Aug 24, 2017Actual

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

May 7, 2019

Last Update Posted Date

May 9, 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

Is FDA Regulated Device

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

This study was conducted to investigate the effects of daily supplementation of Zingiber officinale Roscoe extract on body fat.

Detailed Description

This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Forty subjects were randomly divided into Zingiber officinale Roscoe extract 200 mg or placebo group. The investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and body mass index.

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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Zingiber officinale Roscoe extract 200 mg	Experimental	2 cap/day, 800 mg/cap for 12 weeks	Dietary Supplement: Zingiber officinale Roscoe extract 200 mg
Placebo	Placebo Comparator	Placebo for 12 weeks	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zingiber officinale Roscoe extract 200 mg	Dietary Supplement	2 cap/day, 800 mg/cap for 12 weeks	Zingiber officinale Roscoe extract 200 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes of body fat mass	Body fat mass was measured in study baseline and 12 week	Baseline and 12 week

Secondary Outcomes

Measure	Description	Time Frame
Changes of percent body fat	Percent body fat was measured in study baseline and 12 week	Baseline and 12 week
Changes of fat free mass	Fat Free Mass was measured in study baseline and 12 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age between 19 and 65 years,
BMI 25~29.9 kg/m2
subjects giving written informed consent

Exclusion Criteria:

Significant variation in weight(more 10%) in the past 3 months
Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker
History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery
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
Pregnancy or breast feeding etc,.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder 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	54907	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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

Browse Leaves

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Browse Branches

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