Overview

This trial is active, not recruiting.

Conditions osteoporosis, osteopenia
Treatments standardized extract of olive polyphenols, placebo
Phase phase 2
Sponsor BioActor
Start date September 2008
End date April 2010
Trial size 90 participants
Trial identifier NCT00789425, BA-IMW-POLYPHENOL-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
a standardized extract of olive polyphenols at 250 mg per day + 1000 mg of calcium per day.
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)
Placebo (starch) + 1000 mg of calcium per day.
placebo
Placebo (starch). A supplement with 1000 mg calcium per day will be supplied together with the active treatment.

Primary Outcomes

Measure
Serum levels of Osteocalcin and CTX will be used as bone turnover markers
time frame: 0, 3, 6, and 12 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants from 50 years up to 70 years old.

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.

Additional Information

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
Principal investigator Rafal Filip, MD PhD
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) .
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by BioActor.