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Completed

NCT Number: NCT01734187

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.

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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–55 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, 560-822, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Fermented Cinnamon Vine Powder

Dietary Supplement

Fermented Cinnamon Vine Powder (30g/day)

Placebo

Dietary Supplement

Placebo (30g/day)

Primary outcomes

  1. Changes in abdominal Fat

    Time frame: 12 weeks

    Abdominal Fat was measured in study visit 1(0 week) and visit 3(12 week).

  2. Changes in Body Fat Mass

    Time frame: 12 weeks

    Body Fat Mass was measured in study visit 1(0 week) and visit 3(12 week).

Secondary outcomes

  1. Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol)

    Time frame: 12 weeks

    LDL-C(Low Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).

  2. Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol)

    Time frame: 12 weeks

    HDL-cholesterol(High Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).

  3. Changes in total cholesterol

    Time frame: 12 weeks

    Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).

  4. Changes in Triglycerides

    Time frame: 12 weeks

    Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 27, 2012
Registry last updated
Sep 3, 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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