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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014