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

Conditions

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
Drug: Rubus occidentalis extract
Active Comparator: Rubus occidentalis extract 1800mg
taking Rubus occidentalis extract 1800mg/day for 12weeks
Drug: Rubus occidentalis extract

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

Korea University Anam Hospital

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.

General Publications

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.

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