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Effect of Olive Leaves as Hypoglycemic Agents in Diabetic Subjects

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ClinicalTrials.gov Identifier: NCT01427998
Recruitment Status : Completed
First Posted : September 2, 2011
Last Update Posted : September 2, 2011
Sponsor:
Information provided by (Responsible Party):
Diabetes, Wolfson Medical Center

Brief Summary:

Background: Animal studies indicate that olive leaf extract normalizes blood glucose. We hypothesized that olive leaf extract might be of benefit in human subjects.

Methods: A total of 79 adults with diabetes were randomly assigned to treatment with olive leaf extract capsules or matched placebo. Measures of glucose homeostasis including glucose, insulin and HbA1c were measured and compared by treatment group.


Condition or disease Intervention/treatment Phase
Diabetes Dietary Supplement: olive leaf extract Other: placebo Phase 3

Detailed Description:

The present study is a randomized, double blind, placebo controlled, clinical trial with a 14 week duration. Patients were randomized to treatment with a tablet of olive leaves or matching placebo in 1:1 ratio.

Patients were instructed to consume a diet consistent with ADA recommendations and an exercise training program was prescribed.

Weight, height, systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in all subjects at the beginning and at the end of the study. Venous blood samples were drawn after an overnight fast of not less than 12 hours. Laboratory tests included fasting blood glucose (FBG), HbA1c, insulin, lipid panel and liver and renal function.

A total of 79 subjects (51 men, 28 women) aged 18-79 years with type 2 diabetes mellitus, were recruited from and followed up at an outpatient clinic. The subjects were selected from a series of 93 consecutive diabetic patients. Eligible patients had been diagnosed with T2DM for at least 1 year.

Subjects were randomized to treatment with olive leaf extract pills (1 500 mg pill daily taken orally) or matching placebo. The intervention was prepared as follows: olive leaves were picked from the Barnea cultivar in the Jezreel Valley region of Israel and immediately freeze-dried on dry ice. After the leaves were thoroughly rinsed with sterile distilled water to remove dust, insecticides, and contaminating material, the leaves were ground and successively Soxhlet extracted with hexane for 3 h and 80% aqueous ethanol for 6 h. The alcoholic extract was concentrated under reduced pressure at 25 °C, and reconstituted with 30% ethanol in water.

Olive leaves or placebo tablet was taken once daily orally throughout the study. All subjects continue their stable treatment to diabetes.

Data were analyzed using SPSS v10.0 (SPSS Inc., Chicago, USA). Continuous data were described a mean ± standard deviation and compared by treatment assignment using the t-test for independent samples. Associations between continuous variables were described by calculating the Pearson's correlation coefficients. Nominal variables such as sex and treatment assignment are described using frequency counts and compared by treatment assignment using the chi square test (exact as appropriate). All tests are two-sided and considered significant at p<0.05.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase Three Clinical Intervention Trial of Olive Leaves and Their Extracts in Human Diabetic Subjects
Study Start Date : August 1999
Primary Completion Date : August 2001
Study Completion Date : August 2001

Arm Intervention/treatment
Active Comparator: olive leaf extract
Olive leaf polyphenol concentrate (OLPC) extraction OLPC was prepared from olive leaves as follows (Zaslave et al, 2005) : The leaves were randomly picked from the Barnea cultivar in the Jezreel Valley region of Israel and immediately freeze-dried on dry ice. After the leaves were thoroughly rinsed with sterile distilled water to remove dust, insecticides, and contaminating material, the leaves were ground and successively Soxhlet extracted with hexane for 3 h and 80% aqueous ethanol for 6 h. The alcoholic extract was concentrated under reduced pressure at 25 °C, and reconstituted with 30% ethanol in water.
Dietary Supplement: olive leaf extract
olive leaf extract, 1 pill daily, 500 mg, for a duration of 14 wks
Other Name: Olife
Placebo Comparator: placebo
matched placebo
Other: placebo
placebo



Primary Outcome Measures :
  1. Serum glucose [ Time Frame: 14 weeks ]
    serum glucose


Secondary Outcome Measures :
  1. Plasma insulin [ Time Frame: 14 weeks ]
    Plasma insulin



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults
  • type 2 diabetes

Exclusion Criteria:

  • type 1 diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427998


Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: Julio Wainstein, MD E. Wolfson Medical Center

Responsible Party: Diabetes, Director, Diabetes Unit, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01427998     History of Changes
Other Study ID Numbers: WMC1111
First Posted: September 2, 2011    Key Record Dates
Last Update Posted: September 2, 2011
Last Verified: September 2011

Keywords provided by Diabetes, Wolfson Medical Center:
diabetes
blood glucose
olive leaf extract

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs