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Completed

NCT Number: NCT02108691

Effect of Intake of Glycin Max (L.) Merr. Peel Extract on Body Fat and Body Weight

The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Glycin max (L.) Merr. peel extract on decrement of body fat. The investigators measured decrement of body fat parameters , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), 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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hanyang University

Seoul, 133-791, 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 19-65 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

Glycin max(L.) Merr. peel extract

Dietary Supplement

Glycin max(L.) Merr. peel extract (2.5g/day)

Placebo

Dietary Supplement

Placebo (2.5g/day)

Primary outcomes

  1. Changes in Body Fat Mass

    Time frame: 8 weeks

    Body Fat Mass was measured in study visit 1(0 week) and visit 3(8 week).

Secondary outcomes

  1. Changes in Percent Body Fat

    Time frame: 8 weeks

    Percent Body Fat was measured in study visit 1(0 week) and visit 3(8 week).

  2. Changes in Weight

    Time frame: 8 weeks

    Weight was measured in study visit 1(0 week)and visit 3(8 week).

  3. Changes in BMI(Body Mass Index)

    Time frame: 8 weeks

    BMI(body mass index) was measured in study visit 1(0week) and visit 3(8 week).

  4. Changes in LDLc

    Time frame: 8 weeks

    LDLc was measured in study visit 1(0week) and visit 3(8 week).

  5. Changes in Non-HDLc

    Time frame: 8 weeks

    Non-HDLc was measured in study visit 1(0week) and visit 3(8 week).

  6. Changes in LDLc/HDLc

    Time frame: 8 weeks

    LDLc/HDLc was measured in study visit 1(0week) and visit 3(8 week).

Sponsors and collaborators

Lead sponsor

Hanyang University

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2014
Registry last updated
May 22, 2015

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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