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Completed

NCT Number: NCT03260751

Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat

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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,.

Treatment and study plan

Zingiber officinale Roscoe extract 200 mg

Dietary Supplement

2 cap/day, 800 mg/cap for 12 weeks

Placebo

Dietary Supplement

Placebo for 12 weeks

Primary outcomes

  1. Changes of body fat mass

    Time frame: Baseline and 12 week

    Body fat mass was measured in study baseline and 12 week

Secondary outcomes

  1. Changes of percent body fat

    Time frame: Baseline and 12 week

    Percent body fat was measured in study baseline and 12 week

  2. Changes of fat free mass

    Time frame: Baseline and 12 week

    Fat Free Mass was measured in study baseline and 12 week

  3. Changes of weight

    Time frame: Baseline and 12 week

    Weight was measured in study baseline and 12 week

  4. Changes of body mass index

    Time frame: Baseline and 12 week

    Body mass index was measured in study baseline and 12 week

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 24, 2017
Registry last updated
May 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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