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

Study Overview
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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.

Official Title
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Phase 3 Study of Cranberry on Lipid Profiles in Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: cranberry


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Dietary Supplement: cranberry<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of total to HDL cholesterol ratio |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of lipid profiles (LDL, total cholesterol, HDL and triglyceride) |  | 12 weeks | 
| the change of ox-LDL |  | 12 weeks | 
| the change of fasting plasma glucose |  | 12 weeks | 
| the change of HbA1c |  | 12 weeks | 
| the change of CRP |  | 12 weeks | 
| the change of UAE |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cranberry, total to HDL cholesterol ratio, type 2 diabetes