Efficacy and Safety of Unripe Bokbunja Extract on Improvement of Blood Cholesterol
A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Unripe Bokbunja Extract on Improvement of Blood Cholesterol
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
This study was conducted to investigate the effects of daily supplementation of unripe Bokbunja extract on improvement of blood cholesterol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
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
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 30, 2018
CompletedFirst Posted
Study publicly available on registry
August 28, 2018
CompletedAugust 28, 2018
May 1, 2018
5 months
July 30, 2018
August 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes of Total cholesterol
Changes of total cholesterol were assessed before and after the intervention
12 weeks
Secondary Outcomes (4)
Changes of Lipid profile(total cholesterol, LDL-cholesterol, triglyceride, HDL-cholesterol, free fatty acid, Apolipoprotein A1, Apolipoprotein B, Lipoprotein a, hs-CRP)
12 weeks
Changes of Arteriosclerosis index(total cholesterol/HDL-cholesterol, LDL-cholesterol/HDL-cholesterol, triglyceride/HDL-cholesterol, (total HDL-cholesterol-HDL-cholesterol)/HDL-cholesterol, Apolipoprotein B/Apolipoprotein A1)
12 weeks
Changes of Anthropometric index(weight, body mass index, waist hip ratio, waist, hip, fat percentage, lean body mass)
12 weeks
Changes of Oxidized LDL
12 weeks
Study Arms (2)
unripe Bokbunja Extract
EXPERIMENTALtablet(1 tablet/d, 600 mg/d) for 12 weeks
Placebo
PLACEBO COMPARATORPlacebo for 12 weeks
Interventions
tablet(1 tablet/d, 600 mg/d) for 12 weeks
Eligibility Criteria
You may qualify if:
- age between 20 and 65 years,
- Total cholesterol 200-239 mg/dl
- subjects giving written informed consent
You may not qualify if:
- Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction
- 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,.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Cho JM, Chae J, Jeong SR, Moon MJ, Ha KC, Kim S, Lee JH. The cholesterol-lowering effect of unripe Rubus coreanus is associated with decreased oxidized LDL and apolipoprotein B levels in subjects with borderline-high cholesterol levels: a randomized controlled trial. Lipids Health Dis. 2020 Jul 9;19(1):166. doi: 10.1186/s12944-020-01338-z.
PMID: 32646501DERIVED
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
- Professor, Principal Investigator
Study Record Dates
First Submitted
July 30, 2018
First Posted
August 28, 2018
Study Start
December 1, 2016
Primary Completion
May 1, 2017
Study Completion
February 1, 2018
Last Updated
August 28, 2018
Record last verified: 2018-05