- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00244907
Isoflavones for Promoting Calcium Absorption and Preventing Bone Loss in Post Menopausal Women
Metabolism and Bone Health
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Estrogen is a hormone that activates bone-forming cells and prevents calcium loss and bone breakdown. During menopause, estrogen levels decrease. Insufficient amounts of estrogen may accelerate bone breakdown and inhibit the body's ability to create new bone, thereby leading to bone loss and possibly osteoporosis. Various treatments have been developed to decrease bone loss in post-menopausal women. Actonel, for example, is an FDA-approved drug used to help prevent bone loss.
Phytoestrogens are plant compounds with a structure similar to estrogen. They have also been shown to help reduce the negative effects of menopause. Isoflavones are a particular type of phytoestrogens that are found in soy plants and may act like estrogen in providing possible protection against bone loss. This study will compare the effects of isoflavones (including genistein, a type of isoflavone) versus Actonel on calcium absorption and bone loss in post-menopausal women.
Participants in this double-blind cross-over study will first complete a screening process, which will include answering questions about their health habits, medical history, physical activity, and food patterns. They will then eat one soy bar daily for 3 days. On Day 4, a urine sample will be taken to assess their ability to metabolize phytoestrogen from soybeans. Participants will be randomly assigned to a specific treatment order. Participants will receive 1-4 unique soy isoflavones, followed by Actonel. Treatment phases will be separated by a 50-day washout period. All participants will also take calcium and vitamin D supplements throughout the study. Assessments will include bone density measurements, calcium absorption tests, and blood and urine tests. The study will last approximately 2.5 years.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Indiana
-
West Lafayette, Indiana, United States, 47907
- Purdue University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least 4 years post-menopausal
Exclusion Criteria:
- Not currently taking estrogen replacement therapy or undergoing any treatment for osteoporosis
- Diagnosis of breast cancer
- Results of mammogram suggesting breast cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Genistein vs. Risedronate
Healthy post menopausal women who have been dosed with Ca41.
Intervention, 100 mg Gensitein from soy protein isolate for 50 days.
After a 50 day washout risedronate (Actonel- 5mg per day) for 50 days
|
Gensitein (100 gm) from soy protein isolate Risedronate (5 mg)
Other Names:
|
ACTIVE_COMPARATOR: Genistein dose and source
Healthy post menopausal women will consume 5 products containing varying quantities of genistein from different sources for 50 days each in a randomized order.
Each intervention period is separated by a 50 day washout period.
Intervention: A) 50 mg genistein from soy protein isolate, B) 100 mg genistein from soy protein isolate, C)50 mg genistein from Novasoy, D) 100 mg genistein from Novasoy, E) 100 ng genistein from 50% Novasoy and 50% soy protein isolate
|
Gensitein (100 gm) from soy protein isolate Risedronate (5 mg)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Urinary markers of bone resorption; measured at the end of each treatment phase
Time Frame: Every 50 days
|
Every 50 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum markers of bone resorption and calcium absorption; measured at the end of each treatment phase
Time Frame: Every 50 days
|
Every 50 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Connie M. Weaver, PhD, Purdue University
Publications and helpful links
General Publications
- Spence LA, Lipscomb ER, Cadogan J, Martin B, Wastney ME, Peacock M, Weaver CM. The effect of soy protein and soy isoflavones on calcium metabolism in postmenopausal women: a randomized crossover study. Am J Clin Nutr. 2005 Apr;81(4):916-22. doi: 10.1093/ajcn/81.4.916.
- Jackson GS, Weaver C, Elmore D. Use of accelerator mass spectrometry for studies in nutrition. Nutr Res Rev. 2001 Dec;14(2):317-34. doi: 10.1079/NRR200129.
- Pawlowski JW, Martin BR, McCabe GP, McCabe L, Jackson GS, Peacock M, Barnes S, Weaver CM. Impact of equol-producing capacity and soy-isoflavone profiles of supplements on bone calcium retention in postmenopausal women: a randomized crossover trial. Am J Clin Nutr. 2015 Sep;102(3):695-703. doi: 10.3945/ajcn.114.093906. Epub 2015 Aug 5.
- Nakatsu CH, Armstrong A, Clavijo AP, Martin BR, Barnes S, Weaver CM. Fecal bacterial community changes associated with isoflavone metabolites in postmenopausal women after soy bar consumption. PLoS One. 2014 Oct 1;9(10):e108924. doi: 10.1371/journal.pone.0108924. eCollection 2014.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Osteoporosis
- Bone Diseases, Metabolic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protective Agents
- Estrogens, Non-Steroidal
- Estrogens
- Membrane Transport Modulators
- Protein Kinase Inhibitors
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Anticarcinogenic Agents
- Phytoestrogens
- Risedronic Acid
- Genistein
Other Study ID Numbers
- P50AT000477-06 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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