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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: cranberry

• Registration Number: NCT00695526
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Study First Submitted: 2008-04-11
• Status Verified: 2008-06
• Study First Submitted QC: 2008-06-11
• Study First Posted: 2008-06-12
• Last Update Submitted: 2008-06-14
• Last Update Posted: 2008-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	cranberry	-

Primary Outcome Measures

Name	Time	Method
the change of total to HDL cholesterol ratio	12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan