A Phase 2 interventional study of Standardized Extract of Olive Polyphenols and Placebo in Osteoporosis and Osteopenia, sponsored by BioActor. Completed at 1 site in Poland. Open to female participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-13.
Sponsored by BioActor · Phase 2, Interventional, and Prevention
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) .
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 64 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
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Exclusion Criteria:
a standardized extract of olive polyphenols at 250 mg per day + 1000 mg of calcium per day.
Dietary Supplement: Standardized Extract of Olive Polyphenols
Placebo (starch) + 1000 mg of calcium per day.
Dietary Supplement: Placebo
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.
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
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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