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

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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

U.S. FDA Resources

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:	August 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 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.
Placebo Comparator: 2 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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Poland
Osteoporosis Outpatient of the Institute of Agricultural Medicine
Lublin, Poland, 20-950

Sponsors and Collaborators

BioActor

Investigators


Principal Investigator:	Rafal Filip, MD PhD	Institute of Agricultural Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Filip R, Possemiers S, Heyerick A, Pinheiro I, Raszewski G, Davicco MJ, Coxam V. Twelve-month consumption of a polyphenol extract from olive (Olea europaea) in a double blind, randomized trial increases serum total osteocalcin levels and improves serum lipid profiles in postmenopausal women with osteopenia. J Nutr Health Aging. 2015 Jan;19(1):77-86. doi: 10.1007/s12603-014-0480-x.


Responsible Party:	Hans van der Saag, BioActor
ClinicalTrials.gov Identifier:	NCT00789425 History of Changes
Other Study ID Numbers:	BA-IMW-POLYPHENOL-001
Study First Received:	September 30, 2008
Last Updated:	February 16, 2010
Health Authority:	Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by BioActor:


osteoporosis osteopenia olive extract oleuropein

Additional relevant MeSH terms:


Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 28, 2016