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

Korea University

Status and phase: Completed; Phase 4

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

Treatments: Drug: Rubus occidentalis extract

Study type: Interventional

Funder types: Other

Identifiers

NCT01964703

ED13024

Details and patient eligibility

About

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).

Enrollment: 29 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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29 participants in 3 patient groups, including a placebo group

control

Placebo Comparator group

Rubus occidentalis extract 900mg

Active Comparator group

Description:

taking Rubus occidentalis extract 900mg/day for 12weeks

Treatment:

Drug: Rubus occidentalis extract

Rubus occidentalis extract 1800mg

Active Comparator group

Description:

taking Rubus occidentalis extract 1800mg/day for 12weeks

Treatment:

Drug: Rubus occidentalis extract