Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes

NCT ID: NCT01964703

Last Updated: 2013-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Prediabetes (Impaired Fasting Glucose and/or Impaired Glucose Tolerance)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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control

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Rubus occidentalis extract 900mg

taking Rubus occidentalis extract 900mg/day for 12weeks

Group Type ACTIVE_COMPARATOR

Rubus occidentalis extract

Intervention Type DRUG

Rubus occidentalis extract 1800mg

taking Rubus occidentalis extract 1800mg/day for 12weeks

Group Type ACTIVE_COMPARATOR

Rubus occidentalis extract

Intervention Type DRUG

Interventions

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Rubus occidentalis extract

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University Anam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sin Gon Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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An JH, Kim DL, Lee TB, Kim KJ, Kim SH, Kim NH, Kim HY, Choi DS, Kim SG. Effect of Rubus Occidentalis Extract on Metabolic Parameters in Subjects with Prediabetes: A Proof-of-concept, Randomized, Double-blind, Placebo-controlled Clinical Trial. Phytother Res. 2016 Oct;30(10):1634-1640. doi: 10.1002/ptr.5664. Epub 2016 Jun 9.

Reference Type DERIVED
PMID: 27279471 (View on PubMed)

Other Identifiers

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ED13024

Identifier Type: -

Identifier Source: org_study_id