Efficacy and Safety of Platycodon Grandiflorus Extract(GCWB107) on Decrease of Body Fat

Chonbuk National University

Status: Unknown

Conditions: Body Fat

Treatments: Dietary Supplement: Platycodon Grandiflorus Extract(GCWB107); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04023864

GCWB-BF-PG

Details and patient eligibility

About

This study was conducted to investigate the effects of daily supplementation of Platycodon grandiflorus extract(GCWB107) on decrease of body fat.

Full description

This study was a 12-week, randomized, double-blind, placebo-controlled human trial. 80 subjects were randomly divided into Platycodon grandiflorus extract(GCWB107) group and a placebo group. It is to evaluate the changes in the displayed evaluation items when taking Platycodon grandiflorus extract(GCWB107) extract once a day, in comparison with taking a placebo.

Enrollment: 80 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males and females aged between 19 and 65 years at the screening
• Participants who were BMI 25~29.9 kg/m^2
• Participants who have fully understood the information provided about the study voluntarily decided to participate and agreed to comply with precautions

Exclusion criteria

• Participants who decrease 10% more of weight within 3 months period to the screening examination

• Participants taking for products affecting body weight within 4 weeks before the screening examination(i.e., Improvement of body fat Healthy functional food, contraceptive, steroid drug treatment, female hormone drug treatment) (However, participation is possible after a 4-week withdrawal period prior to the first intake day)

• Participants who drink more than 14 units/week of alcohol intake

• Patients with a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry system, musculoskeletal system, inflammatory and hematologic

• Patients with diabetics who are taking oral hypoglycemic agents and insulin (at the screening)

• Participants with a past history of gastrointestinal diseases (e.g., Crohn's disease) or gastrointestinal surgery (but, excluding simple cecal surgery and hernia surgery) that can affect the absorption of products of the human trial

• Participants who have a history of clinically significant hypersensitivity to balloon flower and saponin components

• Participants receiving antipsychotic medication within 2 months prior to the screening examination

• Participants who were doubtful about drug abuse

• Participants who have participated in other clinical trials within 3 months prior to the screening examination

• Participants who have SBP≥180 mmHg and DBP≥110 mmHg

• Menopause women

• Participants who show the following relevant results in a Laboratory test

  • Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
  • Serum Creatinine > 2.0 mg/dl

• Women who are pregnant or breastfeeding

• Women who may become pregnant and have not used appropriate contraceptives

• Participants who the principal investigator judged inappropriate for the participant in this study because of a laboratory test result, etc

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Platycodon Grandiflorus Extract(GCWB107) group

Experimental group

Description:

Once-daily, once a tablet, after meals (900 mg/day, 571 mg/day as a Platycodon Grandiflorus Extract(GCWB107))

Treatment:

Dietary Supplement: Platycodon Grandiflorus Extract(GCWB107)

Placebo group

Placebo Comparator group

Description:

Once-daily, once a tablet, after meals (900 mg/day, 0 mg/day as a Platycodon Grandiflorus Extract(GCWB107))

Treatment:

Dietary Supplement: Placebo