Investigating the Effect of Standardized Olive Extract on Bone Turnover Markers in Postmenopausal Women
Condition: Osteoporosis; Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 2

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.
    

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) .
    

Intervention name(s): Standardized Extract of Olive Polyphenols; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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 (starch). A supplement with 1000 mg calcium per day will be supplied together with the active treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: osteoporosis; osteopenia; olive extract; oleuropein