Investigating the Effect of Standardized Olive Extract on Bone Turnover Markers in Postmenopausal Women - Full Text View

Sponsored by:	BioActor
Information provided by:	BioActor
ClinicalTrials.gov Identifier:	NCT00789425

Purpose

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.

Condition	Intervention	Phase
Osteoporosis Osteopenia	Dietary Supplement: Standardized Extract of Olive Polyphenols Dietary Supplement: Placebo	Phase II

MedlinePlus related topics: Dietary Supplements Minerals Osteoporosis

Drug Information available for: Starch Calcium gluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by BioActor:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	90
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator a standardized extract of olive polyphenols at 250 mg per day + 1000 mg of calcium per day.	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.
2: Placebo Comparator 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.

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) .

Eligibility

Ages Eligible for Study:	50 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789425

Contacts

Contact: Rafal Filip, MD PhD

+48817184470

r.s.filip@wp.pl

Locations

Poland
Osteoporosis Outpatient of the Institute of Agricultural Medicine	Recruiting
Lublin, Poland, 20-950
Contact: Rafal Filip, MD PhD +48817184470 r.s.filip@wp.pl
Principal Investigator: Rafal Filip, MD PhD

Sponsors and Collaborators

BioActor

Investigators

Principal Investigator:

Rafal Filip, MD PhD

Institute of Agricultural Medicine

More Information

Responsible Party:	BioActor ( Hans van der Saag )
Study ID Numbers:	BA-IMW-POLYPHENOL-001
Study First Received:	September 30, 2008
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00789425
Health Authority:	Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by BioActor:

osteoporosis
osteopenia
olive extract
oleuropein

Study placed in the following topic categories:

Calcium, Dietary
Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on January 16, 2009