Skip to main content
OpenTrials
Completed

NCT Number: NCT00695526

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital

Taichung, 407, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cranberry

Dietary Supplement

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.

Primary outcomes

  1. the change of total to HDL cholesterol ratio

    Time frame: 12 weeks

Secondary outcomes

  1. the change of lipid profiles (LDL, total cholesterol, HDL and triglyceride)

    Time frame: 12 weeks

  2. the change of ox-LDL

    Time frame: 12 weeks

  3. the change of fasting plasma glucose

    Time frame: 12 weeks

  4. the change of HbA1c

    Time frame: 12 weeks

  5. the change of CRP

    Time frame: 12 weeks

  6. the change of UAE

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jun 12, 2008
Registry last updated
Jun 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.