Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes
October 14, 2013 updated by: Sin Gon Kim, Korea University Anam Hospital
Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes; A Proof-of-concept, Randomized, Double-blind, Parallel-group Placebo-controlled Study
The purpose of this study is to determine whether Rubus occidentalis extract could improve fasting or postprandial serum glucose levels, and related metabolic markers among patients with prediabetes (impaired fasting glucose and/or impaired glucose tolerance).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 19 years of age or older
- prediabetes (fasting plasma glucose 100-125mg/dl, and/or post 75g OGTT plasma glucose 140-199mg/dl)
Exclusion Criteria:
- pregnant women
- taking anti-hyperglycemic agents within 3 months at the time of enrollment
- history of heart failure, myocardial infarction, cerebral infarction
- uncontrolled hypertension (systolic BP > 160mmHg, or diastolic BP > 100mmHg)
- serum triglyceride level > 500mg/dl
- kidney dysfunction (serum Creatinine > 30% of upper normal limits)
- hepatic dysfunction (AST, ALT > 3 times of upper normal limits)
- taking systemic glucocorticoids within 1 month
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: control
|
|
|
Active Comparator: Rubus occidentalis extract 900mg
taking Rubus occidentalis extract 900mg/day for 12weeks
|
|
|
Active Comparator: Rubus occidentalis extract 1800mg
taking Rubus occidentalis extract 1800mg/day for 12weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
serum glucose (fasting and post 75g oral glucose tolerance test)
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
serum insulin
Time Frame: 12 weeks
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
HOMA IR, QUICKI, HOMA beta, lipid profile, inflammatory markers
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
October 14, 2013
First Submitted That Met QC Criteria
October 14, 2013
First Posted (Estimate)
October 17, 2013
Study Record Updates
Last Update Posted (Estimate)
October 17, 2013
Last Update Submitted That Met QC Criteria
October 14, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ED13024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.