Pomegranate Extract Biomarker Study in Osteopenic Women

This study has been completed.
Sponsor:
Information provided by:
POM Wonderful LLC
ClinicalTrials.gov Identifier:
NCT01219140
First received: October 8, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Osteopenic Women
Dietary Supplement: 2 POMx Capsules
Dietary Supplement: 2 placebo Capsules
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind, Parallel Design Trial to Evaluate the Safety and Efficacy of Pomegranate Extract Capsules in Post-Menopausal Subjects With Decreased Bone Mineral Density

Resource links provided by NLM:


Further study details as provided by POM Wonderful LLC:

Primary Outcome Measures:
  • Biomarkers [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
    To evaluate the impact of pomegranate extract capsules on urinary N-terminal telopeptide (NTX) and serum procollagen type 1 amino-terminal propeptide (P1NP), in post-menopausal women with decreased bone mineral density


Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
    Incidence of adverse events Changes in vital signs or laboratory values


Enrollment: 64
Study Start Date: May 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 POMx Capsules
2 POMx Capsules daily
Dietary Supplement: 2 POMx Capsules
2 POMx Capsules daily
Placebo Comparator: 2 placebo Capsules
2 placebo Capsules daily
Dietary Supplement: 2 placebo Capsules
2 placebo Capsules daily

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01219140

Locations
United States, Florida
SeaView Research, Inc.
Miami, Florida, United States, 33126
Sponsors and Collaborators
POM Wonderful LLC
  More Information

No publications provided

Responsible Party: POM Wonderful LLC
ClinicalTrials.gov Identifier: NCT01219140     History of Changes
Other Study ID Numbers: POM 2010-001
Study First Received: October 8, 2010
Last Updated: October 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by POM Wonderful LLC:
POMx
Osteopenia
postmenopausal women
Pomegranate

ClinicalTrials.gov processed this record on October 01, 2014