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Pomegranate Extract Biomarker Study in Osteopenic Women

NCT ID: NCT01219140

Last Updated: 2010-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-10-31

Brief Summary

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Treatment of post-menopausal subjects (with decreased bone mineral density) with pomegranate extract capsules will produce statistically significant changes in biomarkers for bone resorption and formation when compared to subjects receiving placebo.

Detailed Description

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Conditions

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Osteopenic Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2 POMx Capsules

2 POMx Capsules daily

Group Type EXPERIMENTAL

2 POMx Capsules

Intervention Type DIETARY_SUPPLEMENT

2 POMx Capsules daily

2 placebo Capsules

2 placebo Capsules daily

Group Type PLACEBO_COMPARATOR

2 placebo Capsules

Intervention Type DIETARY_SUPPLEMENT

2 placebo Capsules daily

Interventions

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2 POMx Capsules

2 POMx Capsules daily

Intervention Type DIETARY_SUPPLEMENT

2 placebo Capsules

2 placebo Capsules daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women (having had their last menstrual period within the past 15 years and an appropriate serum FSH value) 45-65 years of age;
* The subject must have a T score of -1 to -2.5 at the lumbar spine or proximal femur;
* All clinical safety laboratory values at screening and randomization must be either within the reference range or be determined by the investigator and the sponsor to be abnormal, but not clinically significant;
* The patient must have provided written informed consent.

Exclusion Criteria

* The subject has any of the following conditions: connective tissue disease, history of clinically significant renal, hepatic pulmonary, cardiovascular, cerebrovascular, gastrointestinal, metabolic, hematological, endocrinological, urological, immunological, neurologic or psychiatric disorders, unless approved by the sponsor on a case by case basis;
* The subject has a positive test result for Hepatitis B surface antigen or antibody to hepatitis C virus at Screening;
* The subject has a known history of infection with the human immunodeficiency virus (HIV); -
* The subject has used bisphosphonate or fluoride therapy within the past 12 or 24 months, respectively;
* The subject has used denosumab within the past 24 months;
* The subject has used tibolone, parathyroid hormone (or any of its derivatives), systemic glucocorticoids or inhaled glucocorticoids, anabolic steroids or testosterone within the past 6 months;
* The subject has used estrogens, selective estrogen receptor modulators, calcitonin or calcitriol within the past 3 months;
* The subject has hyperparathyroidism, hypoparathyroidsim, hyperthyroidism, hypothyroidism, hypocalcemia, rheumatoid arthritis, paget's disease of bone, osteomalacia;
* The subject has had a bone fracture within the past year;
* The subject has acute or chronic disease requiring frequent changes in medications or dosages of chronic therapy;
* A history of alcoholism within the last 2 years or a current history of imbibing 3 or more units of alcohol per day. (1 unit is equivalent to 1 glass of wine, 1 pint of beer, or 1 shot of hard liquor);
* The subject has participated in another study with an investigational drug or device during the 30 days prior to study entry;
* The subject has a condition interfering with his ability to provide informed consent or comply with study instructions, or the patient has a condition, which might confound the interpretation of the study result;
* The subject has a condition endangering herself if she were to participate in this trial
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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POM Wonderful LLC

INDUSTRY

Sponsor Role lead

Locations

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SeaView Research, Inc.

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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POM 2010-001

Identifier Type: -

Identifier Source: org_study_id