ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigating the Effect of Standardized Olive Extract on Bone Turnover Markers in Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00789425
Recruitment Status : Completed
First Posted : November 11, 2008
Last Update Posted : July 13, 2017
Sponsor:
Information provided by:
BioActor

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine whether the intake of a daily dosage of standardized olive extract provides any protection against bone loss.

Condition or disease Intervention/treatment Phase
Osteoporosis Osteopenia Dietary Supplement: Standardized Extract of Olive Polyphenols Dietary Supplement: Placebo Phase 2

Detailed Description:

Apart from estrogen deficiency, the early postmenopausal period is also characterised by an increasing inflammatory and oxidant status, which further contributes to the development of osteoporosis/osteopenia. The link between systemic inflammation and osteoporosis has only been established recently as it was found that higher circulating hsCRP levels are associated with lower bone mineral density in both healthy pre- and postmenopausal women. Furthermore, it was already known for a long time that one of the most important cytokines implicated in the pathogenesis of various metabolic bone diseases, including postmenopausal osteoporosis, is interleukin (IL)-6, which is produced by osteoblasts, monocytes and T-cells.

Olive oil is the principle fat source of the traditional Mediterranean diet, a diet that has been associated with a low incidence of some diseases, including coronary heart disease and osteoporosis. In addition to the main ingredient (ie. oleic acid) extra virgin olive oil also contains phenolic compounds, such as oleuropein- and ligstroside-aglycones and their derivatives. They are formed in olives by enzymatic removal of glucose from the polar parent compound oleuropein-glycoside. A Mediterranean diet rich in olive oil supplies 10 - 20 mg of phenols per day.

The main metabolic attribute of oleuropein is that it exerts both antioxidant and anti-inflammatory activity by lowering the levels of proinflammatory cytokines like IL-1, IL-6 or TNF-alpha. By inhibiting osteoclast activity, this may result in lowering the rate of bone resorption and, at least in part, protect against osteoporosis development.

Formulated as a capsule it is expected that the compliance and tolerability will be improved compared to the liquid administration. The present study is designed to investigate the effect of 250 mg of a standardized extract of olive polyphenols per day on bone loss in postmenopausal women with decreased bone mass (osteopenia) .


Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised, Double Blind, Parallel Group, 12-month Comparison of a Standardized Olive Extract With Placebo in Postmenopausal Women With Decreased Bone Mineral Density
Study Start Date : September 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: 1
a standardized extract of olive polyphenols at 250 mg per day + 1000 mg of calcium per day.
 Dietary Supplement: Standardized Extract of Olive Polyphenols

Dietary supplement containing 250 mg of a standardized extract of olive polyphenols per day in 1 capsule.

A supplement with 1000 mg calcium per day will be supplied together with the active treatment.
Placebo Comparator: 2
Placebo (starch) + 1000 mg of calcium per day.
 Dietary Supplement: Placebo
Placebo (starch). A supplement with 1000 mg calcium per day will be supplied together with the active treatment.


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Serum levels of Osteocalcin and CTX will be used as bone turnover markers [ Time Frame: 0, 3, 6, and 12 months ]

Secondary Outcome Measures :
  1. Bone mineral density as measured by DEXA in lumbar spine and total hip [ Time Frame: 0 and 12 months ]
  2. hs-CRP and IL-6 in serum as inflammation markers [ Time Frame: 0, 6, and 12 months ]
  3. ORAC values in serum as oxidative stress marker [ Time Frame: 0, 6, and 12 months ]
  4. Total cholesterol, HDL-C, LDL-C, triglycerides in serum as CVD-risk markers. [ Time Frame: 0, 6, and 12 months ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed written informed consent
  • Gender female
  • Between 50-70 years of age
  • At least 2 years post menopause
  • Bone mineral density (BMD) < or equal to -1.5 and > or equal to -2.5 SD% Young Adult
  • Patients with stabilised food habits
  • Patients able to understand the nature of the study and able to give signed written informed consent.

Exclusion Criteria:

  • Patients with any diseases affecting bone tissue e.g. primary hyperparathyroidism.
  • Patients during any therapy affecting bone tissue e.g. HRT, corticosteroids.
  • Patients with any associated illness of sufficient severity, or clinically relevant abnormalities in the pre-study screening, which in the opinion of the investigator would make them unsuitable for inclusion in the study, e.g. severe heart failure, severe ischaemic heart disease etc.
  • Planned hospitalisation (major surgery) during the study.
  • Patients who have any known allergy or intolerance to any compound in the test product.
  • Patients who are unwilling or unable to comply with the study protocol for any other reason.
Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00789425


Locations
Poland
Osteoporosis Outpatient of the Institute of Agricultural Medicine
Lublin, Poland, 20-950
Sponsors and Collaborators
BioActor
Investigators
Principal Investigator: Rafal Filip, MD PhD Institute of Agricultural Medicine
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hans van der Saag, BioActor
ClinicalTrials.gov Identifier: NCT00789425     History of Changes
Other Study ID Numbers: BA-IMW-POLYPHENOL-001
First Posted: November 11, 2008    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017

Keywords provided by BioActor:
osteoporosis
osteopenia
olive extract
oleuropein

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Metabolic Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs