Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Zingiber officinale Roscoe extract 200 mg; Dietary Supplement: Placebo

• Registration Number: NCT03260751
• Lead Sponsor: Chonbuk National University Hospital

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.

Study Timeline

• Study Start: 2017-02-03
• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-22
• Study First Posted: 2017-08-24
• Primary Completion: 2018-01-29
• Study Completion: 2018-01-29
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-07
• Last Update Posted: 2019-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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,.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zingiber officinale Roscoe extract 200 mg	Zingiber officinale Roscoe extract 200 mg	2 cap/day, 800 mg/cap for 12 weeks
Placebo	Placebo	Placebo for 12 weeks

Primary Outcome Measures

Name	Time	Method
Changes of body fat mass	Baseline and 12 week	Body fat mass was measured in study baseline and 12 week

Secondary Outcome Measures

Name	Time	Method
Changes of percent body fat	Baseline and 12 week	Percent body fat was measured in study baseline and 12 week
Changes of fat free mass	Baseline and 12 week	Fat Free Mass was measured in study baseline and 12 week
Changes of weight	Baseline and 12 week	Weight was measured in study baseline and 12 week
Changes of body mass index	Baseline and 12 week	Body mass index was measured in study baseline and 12 week

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of