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Postmenopausal Women Sought for Study Evaluating the Use of Soy Isoflavones to Prevent Osteoporosis
Contact:
Tonya Dalton, UGA Research Coordinator, opus@fcs.uga.edu, 706-583-0040
Rick Lewis, UGA Project Director, rlewis@fcs.uga.edu
Healthy, post-menopausal women, (40 to 60 years old) needed for a study designed to test soy isoflavone supplementation to prevent osteoporosis.
Prospective recruits in this two-year study, sponsored by the United States Department of Agriculture, can not have osteoporosis, can not be vegetarian, and can not currently be taking hormone replacement therapy.
Participants will receive modest compensation for their involvement in the study.
National OPUS Website
If you are interested, please contact the OPUS Study Coordinator at the University of Georgia at 706-583-0040, or opus@fcs.uga.edu.
Nutrition Researchers To Determine If Soy Can Reduce Bone Loss
Nutrition researchers at The University of Georgia are searching for women interested in learning whether soy isoflavones can reduce bone loss following menopause.
Primary investigator, Dr. William Wong of Baylor College of Medicine in Houston, Texas leads the project titled, Safety, Efficacy, and Optimal Dosage of Soy Isoflavones to Prevent Osteoporosis. The Osteoporosis Prevention Using Soy (OPUS) isoflavone study is a four-year, $5 million project funded by the U.S. Department of Agriculture. Baylor College of Medicine, The University of Georgia, and the University of California at Davis are the three sites in the United States that will study the benefits of soy isoflavones.
Approximately 20 million women in America have osteoporosis, which runs up a tab of $15 billion annually for inpatient care, according to Dr. Richard Lewis, a professor in the department of Foods and Nutrition, College of Family and Consumer Sciences and project director for the Georgia Site. The costs of lost wages for those who suffer fractures or for their caregivers makes the annual cost even higher, he added.
Although research has shown that estrogen-replacement therapy (ERT) can reduce bone loss significantly, there are some concerns of increased risks of cancer with ERT. Because previous studies with soy isoflavones have shown no increase in health risks, researchers hope it can provide a viable alternative to current medications.
"Soy is one of the several products that some women are using to minimize the symptoms of menopause, but there's been limited research demonstrating its efficacy or safety in preventing osteoporosis. This study has three components: establishing whether there are bone health benefits to soy isoflavones, determining if there are risks associated with soy isoflavone supplementation, and communicating those results in readily understandable terms to consumers," Lewis said.
The study builds on two small separate studies that show soy isoflavones, plant hormones that have estrogen-like properties, have beneficial effects on bone mineral density and bone mineral content.
The OPUS study will include 400 multi-ethnic, healthy, post-menopausal women, who will be followed for two years. One-third of the women will receive a placebo; one-third will receive soy isoflavone supplementation at 80 milligrams per day; and one-third will receive 120 milligrams of the supplement per day.
The women will undergo bone scans to determine whether bone mineral density is decreasing, remaining the same, or increasing. Also, to establish the safety of supplements, study participants will undergo a series of medical tests, including mammograms and Pap smears, and blood chemistries.
A strong component of the research is conveying the findings to several audiences, including doctors and other medical professionals, nutritionists, and Cooperative Extension faculty, who frequently provide nutrition workshops to the public. In addition, an interactive seminar targeting high school science teachers and top high school students is planned.
"Too often the results of this type of applied research are not adequately conveyed," Lewis said. "By thoroughly educating as many different audiences as possible about our findings - whether those findings support the use of soy or not - women will be able to work more effectively with their physicians in deciding what's right for them following menopause."
Women interested in participating in the research study should be healthy, post-menopausal, and 40 to 60 years old. Women who have had their ovaries removed may also participate if they are at least six months post-surgery and meet other criteria.
Frequently Asked Questions
What exactly is involved in the study (what do the women have to do)?
Women are asked to visit the UGA Bone Research Clinic located in Athens, GA for all baseline testing procedures. Once women are enrolled into the Osteoporosis Prevention Using Soy study (OPUS) they are required to take the study supplements including the calcium and multi-vitamin supplements provided by the study, everyday, continuously for 2 years, and to visit the UGA Bone Research Clinic for the physical exam, Pap smear, blood chemistry, and bone mineral density test every year for 2 years.
What are the benefits of the study?
Over the two year duration of the study, each participant will receive free bone mineral density tests, blood work, physical exams, and a supply of a multivitamin and mineral supplement and calcium carbonate (total of over $1000 value per year).
Do I get paid?
If you complete the baseline testing and get enrolled into the Osteoporosis Prevention Using Soy (OPUS) study you will receive $25. If you take the study supplements for the first year and return to the UGA Bone Research Clinic for the 1-year testing date you will receive $50. If you continue to take the study supplements for the 2nd year and return to the lab for the 2-year testing date, you will receive $100.
How long does the study last?
The study lasts approximately 2.5 years. Participants take the study supplements for 2 years.
Do I have to live in Athens to participate?
No, the staff will make every effort to make travel and testing arrangements as conveinient as possible.
Where do I go to participate?
All testing will be conducted at the UGA Bone Research Clinic in Athens, Georgia.
How often do I have to visit the clinic?
The number of times a participant visits depends on what is most convenient for them. Number of visits may range from 2-5 per year for the two year study duration.
How long does each visit last?
Length of visits depends on what testing is being done.
- Bone mineral density test: 30 minutes - 1 hour.
- Blood work: 15 minutes.
- Physical exam : 15 minutes.
- Questionnaires: 1 hour and 30 minutes - 2 hours.
Who provides the supplements?
The Osteoporosis Prevention Using Soy (OPUS) study provides all supplements.
When does the study start or when do I start?
The start date is unique to each individual, meaning the two year testing period starts differently for each study volunteer depending on the date they complete baseline screening and are individually enrolled into the Osteoporosis Prevention Using Soy study (OPUS).
Are there side effects of taking soy isoflavones?
Based on the research up to date, we do not expect any side effects. However, there are possible side effects to taking soy isoflavone supplements such as allergic reactions, but no side effects have been reported from current enrolled volunteers.
What are soy isoflavones and how do they compare to estrogen?
Soy isoflavones are a class of phytochemicals that are extracted from soybeans. Soy isoflavones are a type of phytoestrogen, or plant hormone, that resembles human estrogen in chemical structure yet are weaker. Soy isoflavones mimic human estrogen at certain sites in the body, and may decrease bone resorption and sustain bone formation.
Can I be sure to get the soy isoflavone supplement?
No, the OPUS study is a double-blind, randomized, placebo controlled study. Since there is a placebo involved in the study, volunteers are not guaranteed to receive the soy isoflavone supplement.
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Osteoporosis Prevention Using Soy
