Effect of Olive Leaves as Hypoglycemic Agents in Diabetic Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Diabetes, Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01427998
First received: August 3, 2011
Last updated: September 1, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Diabetes
Dietary Supplement: olive leaf extract
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase Three Clinical Intervention Trial of Olive Leaves and Their Extracts in Human Diabetic Subjects

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • Serum glucose [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    serum glucose


Secondary Outcome Measures:
  • Plasma insulin [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    Plasma insulin


Enrollment: 79
Study Start Date: August 1999
Study Completion Date: August 2001
Primary Completion Date: August 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults
  • type 2 diabetes

Exclusion Criteria:

  • type 1 diabetes
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01427998

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

No publications provided

Responsible Party: Diabetes, Director, Diabetes Unit, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01427998     History of Changes
Other Study ID Numbers: WMC1111
Study First Received: August 3, 2011
Last Updated: September 1, 2011
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014