Pomegranate Extract Biomarker Study in Osteopenic Women

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

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.

Study Overview

• Status: Completed
• Conditions: Osteopenic Women
• Intervention / Treatment: Dietary supplement: 2 POMx Capsules; Dietary supplement: 2 placebo Capsules

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • SeaView Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers	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	Throughout study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Incidence of adverse events Changes in vital signs or laboratory values	Throughout study

Collaborators and Investigators

• Sponsor: POM Wonderful LLC

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: October 8, 2010
• First Submitted That Met QC Criteria: October 8, 2010
• First Posted (Estimate): October 13, 2010

Study Record Updates

• Last Update Posted (Estimate): October 13, 2010
• Last Update Submitted That Met QC Criteria: October 8, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: postmenopausal women; Pomegranate; Osteopenia; POMx
• Other Study ID Numbers: POM 2010-001