NCT00789425

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

1.5 years

First QC Date

September 30, 2008

Last Update Submit

July 12, 2017

Conditions

OsteoporosisOsteopenia

Keywords

osteoporosisosteopeniaolive extractoleuropein

Outcome Measures

Primary Outcomes (1)

  • Serum levels of Osteocalcin and CTX will be used as bone turnover markers

    0, 3, 6, and 12 months

Secondary Outcomes (4)

  • Bone mineral density as measured by DEXA in lumbar spine and total hip

    0 and 12 months

  • hs-CRP and IL-6 in serum as inflammation markers

    0, 6, and 12 months

  • ORAC values in serum as oxidative stress marker

    0, 6, and 12 months

  • Total cholesterol, HDL-C, LDL-C, triglycerides in serum as CVD-risk markers.

    0, 6, and 12 months

Study Arms (2)

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

2

PLACEBO COMPARATOR

Placebo (starch) + 1000 mg of calcium per day.

Dietary Supplement: Placebo

Interventions

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.

1
PlaceboDIETARY_SUPPLEMENT

Placebo (starch). A supplement with 1000 mg calcium per day will be supplied together with the active treatment.

2

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with any diseases affecting bone tissue e.g. primary hyperparathyroidism.
  • Patients during any therapy affecting bone tissue e.g. HRT, corticosteroids.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osteoporosis Outpatient of the Institute of Agricultural Medicine

Lublin, 20-950, Poland

Location

Related Publications (1)

  • 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.

    PMID: 25560820DERIVED

MeSH Terms

Conditions

OsteoporosisBone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Rafal Filip, MD PhD

    Institute of Agricultural Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 30, 2008

First Posted

November 11, 2008

Study Start

September 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

PL(1)