Isoflavones for Promoting Calcium Absorption and Preventing Bone Loss in Post Menopausal Women
| Status: | Completed |
|---|---|
| Conditions: | Osteoporosis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Rheumatology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/6/2018 |
| Start Date: | January 2006 |
| End Date: | May 2010 |
Metabolism and Bone Health
Estrogen is a hormone that helps prevent calcium loss and bone breakdown. During menopause,
estrogen levels decrease. Insufficient amounts of estrogen may lead to bone loss and possibly
osteoporosis. Isoflavones are natural compounds found in soy plants that may help provide
protection against bone loss. This study will evaluate the effect of soy isoflavones on
calcium absorption and bone loss in post menopausal women.
estrogen levels decrease. Insufficient amounts of estrogen may lead to bone loss and possibly
osteoporosis. Isoflavones are natural compounds found in soy plants that may help provide
protection against bone loss. This study will evaluate the effect of soy isoflavones on
calcium absorption and bone loss in post menopausal women.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
