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

T

Taichung Veterans General Hospital

Status and phase

Completed
Phase 3

Conditions

Type 2 Diabetes

Treatments

Dietary Supplement: cranberry

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

30 participants in 1 patient group

A
Active Comparator group
Treatment:
Dietary Supplement: cranberry

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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