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Effect of Olive Leaves as Hypoglycemic Agents in Diabetic Subjects

Sponsor
Wolfson Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01427998
Collaborator
(none)
79
Enrollment
2
Arms
24
Duration (Months)

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
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 :
Aug 1, 1999
Actual Primary Completion Date :
Aug 1, 2001
Actual Study Completion Date :
Aug 1, 2001

Arms and Interventions

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 Names:
  • Olife

    		•
    Placebo Comparator: placebo

    matched placebo

    Other: placebo
    placebo

    Outcome Measures

    Primary Outcome Measures

    1. Serum glucose [14 weeks]

      serum glucose

    Secondary Outcome Measures

    1. Plasma insulin [14 weeks]

      Plasma insulin

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • adults

    • type 2 diabetes

    Exclusion Criteria:
    • type 1 diabetes

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Wolfson Medical Center

    Investigators

    • Principal Investigator: Julio Wainstein, MD, E. Wolfson Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Diabetes, Director, Diabetes Unit, Wolfson Medical Center
    ClinicalTrials.gov Identifier:
    NCT01427998
    Other Study ID Numbers:
    • WMC1111
    First Posted:
    Sep 2, 2011
    Last Update Posted:
    Sep 2, 2011
    Last Verified:
    Sep 1, 2011
    Keywords provided by Diabetes, Director, Diabetes Unit, Wolfson Medical Center
    diabetes
    blood glucose
    olive leaf extract

    Study Results

    No Results Posted as of Sep 2, 2011