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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695526
• Other study ID #: C06066
• Status: Completed
• Phase: Phase 3
• First received: April 11, 2008
• Last updated: June 14, 2008
• Start date: May 2006
• Est. completion date: October 2006

Study information

• Verified date: June 2008
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Taiwan	outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of total to HDL cholesterol ratio		12 weeks	No
Secondary	the change of lipid profiles (LDL, total cholesterol, HDL and triglyceride)		12 weeks	No
Secondary	the change of ox-LDL		12 weeks	No
Secondary	the change of fasting plasma glucose		12 weeks	No
Secondary	the change of HbA1c		12 weeks	No
Secondary	the change of CRP		12 weeks	No
Secondary	the change of UAE		12 weeks	No