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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by BioActor.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
BioActor
ClinicalTrials.gov Identifier:
NCT00789425
First received: September 30, 2008
Last updated: February 16, 2010
Last verified: February 2010

September 30, 2008
February 16, 2010
September 2008
April 2010   (final data collection date for primary outcome measure)
Serum levels of Osteocalcin and CTX will be used as bone turnover markers [ Time Frame: 0, 3, 6, and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00789425 on ClinicalTrials.gov Archive Site
  • Bone mineral density as measured by DEXA in lumbar spine and total hip [ Time Frame: 0 and 12 months ] [ Designated as safety issue: No ]
  • hs-CRP and IL-6 in serum as inflammation markers [ Time Frame: 0, 6, and 12 months ] [ Designated as safety issue: No ]
  • ORAC values in serum as oxidative stress marker [ Time Frame: 0, 6, and 12 months ] [ Designated as safety issue: No ]
  • Total cholesterol, HDL-C, LDL-C, triglycerides in serum as CVD-risk markers. [ Time Frame: 0, 6, and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Investigating the Effect of Standardized Olive Extract on Bone Turnover Markers in Postmenopausal Women
A Randomised, Double Blind, Parallel Group, 12-month Comparison of a Standardized Olive Extract With Placebo in Postmenopausal Women With Decreased Bone Mineral Density

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.

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) .

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Osteoporosis
  • Osteopenia
  • 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.

  • Dietary Supplement: Placebo
    Placebo (starch). A supplement with 1000 mg calcium per day will be supplied together with the active treatment.
  • Active Comparator: 1
    a standardized extract of olive polyphenols at 250 mg per day + 1000 mg of calcium per day.
    Intervention: Dietary Supplement: Standardized Extract of Olive Polyphenols
  • Placebo Comparator: 2
    Placebo (starch) + 1000 mg of calcium per day.
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
August 2010
April 2010   (final data collection date for primary outcome measure)

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.
Female
50 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT00789425
BA-IMW-POLYPHENOL-001
No
Hans van der Saag, BioActor
BioActor
Not Provided
Principal Investigator: Rafal Filip, MD PhD Institute of Agricultural Medicine
BioActor
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP