NCT04023864

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

December 2, 2019

Status Verified

November 1, 2019

Enrollment Period

1.7 years

First QC Date

July 16, 2019

Last Update Submit

November 28, 2019

Conditions

Body Fat

Keywords

Platycodon Grandiflorus ExtractBody Fat

Outcome Measures

Primary Outcomes (1)

  • Changes of body fat mass

    Body fat mass was measured in study baseline and 12 week.

    0 week and 12 week

Secondary Outcomes (5)

  • Changes of percent body fat

    0 week and 12 week

  • Changes of fat free mass

    0 week and 12 week

  • Changes of Anthropometric indicators

    Screening, 0 week, and 12 week

  • Changes of indicator of lipid metabolism

    0 week and 12 week

  • Changes of Obesity-related hormone index

    0 week and 12 week

Study Arms (2)

Platycodon Grandiflorus Extract(GCWB107) group

EXPERIMENTAL

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

Dietary Supplement: Platycodon Grandiflorus Extract(GCWB107)

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Platycodon Grandiflorus Extract(GCWB107)DIETARY_SUPPLEMENT

Once-daily, once a tablet, after meals, for 12 week

Platycodon Grandiflorus Extract(GCWB107) group
PlaceboDIETARY_SUPPLEMENT

Placebo for 12 week

Placebo group

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

RECRUITING

Central Study Contacts

Soo Wan Chae, Ph.D., M.D.

CONTACT

82-63-259-3040soowan@jbnu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Trial Center for Functional Foods

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 18, 2019

Study Start

October 19, 2018

Primary Completion

June 30, 2020

Study Completion

November 30, 2020

Last Updated

December 2, 2019

Record last verified: 2019-11

Locations

KR(1)