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Effects of Cranberry Extractive on the Lipid Profiles in Subjects With Type 2 Diabetes

NCT ID: NCT00695526

Last Updated: 2008-06-17

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

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-10-31

Brief Summary

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Cranberry, containing flavonoids, is effective on improvement of lipid profiles in non-diabetic subjects. The Hypothesis of is to assess the effect of cranberry on lipid profiles in type 2 diabetic patients using oral antidiabetic drugs.

Detailed Description

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Hypercholesterolemia is a notorious risk factor for cardiovascular disease. It had been reported cranberry consumption increased nearly 8% of circulating high-density lipoprotein (HDL) cholesterol levels in non-diabetic subjects. Although characteristics of diabetic dyslipidemia are low HDL and high triglyceride, the benefits of concentrated powder of cranberry juice on lipid profiles were not evident in type 2 diabetic subjects with diet control alone. To the best of our knowledge, the effect of cranberry on lipid profiles in type 2 diabetic subjects using oral anti-diabetic drugs have never been studied, especially total to HDL cholesterol ratio which is important in predicting cardiovascular diseases in Asian and/or diabetic population. Furthermore, cranberry has anti-oxidative effect which is associated with reduction of oxidized low-density lipoprotein (ox-LDL) cholesterol in non-diabetes. Therefore, we conducted a placebo-controlled, double-blind, randomized study to assess the effect of cranberry on lipid profiles in type 2 diabetes.

Conditions

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Type 2 Diabetes

Keywords

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cranberry total to HDL cholesterol ratio type 2 diabetes

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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A

Group Type ACTIVE_COMPARATOR

cranberry

Intervention Type DIETARY_SUPPLEMENT

cranberry extractive in powder product (by Triarco Industries, Inc. NJ, USA) and encapsulated in dose of 500mg/capsule (by Topo digital tech co., Taiwan). By one capsule after each of three meals per day.

Interventions

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cranberry

cranberry extractive in powder product (by Triarco Industries, Inc. NJ, USA) and encapsulated in dose of 500mg/capsule (by Topo digital tech co., Taiwan). By one capsule after each of three meals per day.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* type 2 diabetic subjects
* age between 50 and 75 years

Exclusion Criteria

* glycosylated hemoglobin (HbA1c) less than 7% or more than 10%;
* triglyceride more than 4.5 mmol/L;
* current insulin treatment;
* change of the medications for anti-diabetes, hypertension, hyperlipidemia and anti-platelet in recent four weeks;
* abnormal renal function (serum creatinine \> 177 μmol/L;
* abnormal liver function test results (more than two-fold upper limit of normal range);
* severe systemic disease such as immune disorder, cancer, acute or chronic inflammation disease;
* smoking in recent 1 year;
* alcoholism (more than two drinks daily);
* using steroid or drugs with unknown components;
* pregnancy or breast-feeding.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Taichung Veterans General Hospital

Principal Investigators

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I Te Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Taichung Veterans General Hospital

Locations

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outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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C06066

Identifier Type: -

Identifier Source: org_study_id