OsteoporosisPhase 2NCT00789425
Investigating the Effect of Standardized Olive Extract on Bone Turnover Markers in Postmenopausal Women
A Phase 2 study testing Standardized Extract of Olive Polyphenols in people with Osteoporosis and Osteopenia, run by BioActor at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia
- What is being tested?
- Standardized Extract of Olive Polyphenols
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2008to Mar 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Osteoporosis Outpatient of the Institute of Agricultural Medicine
Lublin, 20-950
About this 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
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.
Read the 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) .
- Conditions
- Osteoporosis, Osteopenia
- Being tested
- Standardized Extract of Olive Polyphenols, Placebo
- Keywords
- osteoporosis, osteopenia, olive extract, oleuropein
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Extract of Olive PolyphenolsDietary supplement
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.
PlaceboDietary supplement
Placebo (starch). A supplement with 1000 mg calcium per day will be supplied together with the active treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | a standardized extract of olive polyphenols at 250 mg per day + 1000 mg of calcium per day. Receives: Dietary Supplement: Standardized Extract of Olive Polyphenols |
| 2 | Placebo comparator | Placebo (starch) + 1000 mg of calcium per day. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of Osteocalcin and CTX will be used as bone turnover markers
Measured: 0, 3, 6, and 12 months
Secondary outcomes (4)
Bone mineral density as measured by DEXA in lumbar spine and total hip
Measured: 0 and 12 months
hs-CRP and IL-6 in serum as inflammation markers
Measured: 0, 6, and 12 months
ORAC values in serum as oxidative stress marker
Measured: 0, 6, and 12 months
Total cholesterol, HDL-C, LDL-C, triglycerides in serum as CVD-risk markers.
Measured: 0, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioActor
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rafal Filip, MD PhD, Principal investigator, Institute of Agricultural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789425
- Sponsor's protocol ID
- BA-IMW-POLYPHENOL-001
- Status last verified
- Jul 2017
- First submitted
- 30 Sep 2008
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25560820
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00789425
- Acronym / sponsor ID
- BA-IMW-POLYPHENOL-001
- Conditions
- Osteoporosis, Osteopenia
- Keywords
- osteoporosis, osteopenia, olive extract, oleuropein
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- BioActorIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Standardized Extract of Olive Polyphenolsa standardized extract of olive polyphenols at 250 mg per day + 1000 mg of calcium per day. |
| 2 | Placebo comparator | Dietary Supplement: PlaceboPlacebo (starch) + 1000 mg of calcium per day. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Extract of Olive PolyphenolsDietary 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. | Dietary supplement | 1 |
| PlaceboPlacebo (starch). A supplement with 1000 mg calcium per day will be supplied together with the active treatment. | Dietary supplement | 2 |
Primary outcome
Serum levels of Osteocalcin and CTX will be used as bone turnover markers
Time frame: 0, 3, 6, and 12 months
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Derived from this study: PubMed 25560820Filip 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafal Filip, MD PhD principal investigator
Institute of Agricultural Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standardized Extract of Olive Polyphenols in people with Osteoporosis and Osteopenia, run by BioActor at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of Osteocalcin and CTX will be used as bone turnover markers (time frame: 0, 3, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00789425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.