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

This study has been completed.
Sponsor:
Information provided by:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT00695526
First received: April 11, 2008
Last updated: June 14, 2008
Last verified: June 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Dietary Supplement: cranberry
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Cranberry on Lipid Profiles in Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taichung Veterans General Hospital:

Primary Outcome Measures:
  • the change of total to HDL cholesterol ratio [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the change of lipid profiles (LDL, total cholesterol, HDL and triglyceride) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • the change of ox-LDL [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • the change of fasting plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • the change of HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • the change of CRP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • the change of UAE [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2006
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A 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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00695526

Locations
Taiwan
outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
Taichung, Taiwan, 407
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
Principal Investigator: I Te Lee, MD Taichung Veterans General Hospital
  More Information

No publications provided

Responsible Party: Department of Medical Education and Research, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT00695526     History of Changes
Other Study ID Numbers: C06066
Study First Received: April 11, 2008
Last Updated: June 14, 2008
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taichung Veterans General Hospital:
cranberry
total to HDL cholesterol ratio
type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013