Investigating the Effect of Standardized Olive Extract on Bone Turnover Markers in Postmenopausal Women
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ClinicalTrials.gov Identifier: NCT00789425 |
Recruitment Status
:
Completed
First Posted
: November 11, 2008
Last Update Posted
: July 13, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoporosis Osteopenia | Dietary Supplement: Standardized Extract of Olive Polyphenols Dietary Supplement: Placebo | Phase 2 |
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 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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
a standardized extract of olive polyphenols at 250 mg per day + 1000 mg of calcium per day.
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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.
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- Serum levels of Osteocalcin and CTX will be used as bone turnover markers [ Time Frame: 0, 3, 6, and 12 months ]
- Bone mineral density as measured by DEXA in lumbar spine and total hip [ Time Frame: 0 and 12 months ]
- hs-CRP and IL-6 in serum as inflammation markers [ Time Frame: 0, 6, and 12 months ]
- ORAC values in serum as oxidative stress marker [ Time Frame: 0, 6, and 12 months ]
- Total cholesterol, HDL-C, LDL-C, triglycerides in serum as CVD-risk markers. [ Time Frame: 0, 6, and 12 months ]

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

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
Poland | |
Osteoporosis Outpatient of the Institute of Agricultural Medicine | |
Lublin, Poland, 20-950 |
Principal Investigator: | Rafal Filip, MD PhD | Institute of Agricultural Medicine |
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 |