NCT01427998

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Aug 1999

Typical duration for phase_3 diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2001

Completed
10 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 2, 2011

Completed
Last Updated

September 2, 2011

Status Verified

September 1, 2011

Enrollment Period

2 years

First QC Date

August 3, 2011

Last Update Submit

September 1, 2011

Conditions

Diabetes

Keywords

diabetesblood glucoseolive leaf extract

Outcome Measures

Primary Outcomes (1)

  • Serum glucose

    serum glucose

    14 weeks

Secondary Outcomes (1)

  • Plasma insulin

    14 weeks

Study Arms (2)

olive leaf extract

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

matched placebo

Other: placebo

Interventions

olive leaf extractDIETARY_SUPPLEMENT

olive leaf extract, 1 pill daily, 500 mg, for a duration of 14 wks

Also known as: Olife
olive leaf extract
placeboOTHER

placebo

placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults
  • type 2 diabetes

You may not qualify if:

  • type 1 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

olive leaf extract

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Julio Wainstein, MD

    E. Wolfson Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Diabetes Unit

Study Record Dates

First Submitted

August 3, 2011

First Posted

September 2, 2011

Study Start

August 1, 1999

Primary Completion

August 1, 2001

Study Completion

August 1, 2001

Last Updated

September 2, 2011

Record last verified: 2011-09