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A randomized double blind controlled trial was conducted to evaluate the effect of daily supplementation with soy isoflavone 100 mg/day for 12 months on 182 postmenopausal women aged 47 to 60 years at subdistrict South Jakarta Indonesia. The study hypothesis was supplementation soy isoflavone 100 mg/day for 6 and 12 months can increase endothelial function.
The subject were randomized to the intervention group receiving tablets consisting of 100 mg soy isoflavone and calcium carbonate 500 mg and the control group receiving 500 mg calcium carbonate for 1 year. This study was carried out 13 months(13 x 28 days).
There were three outcome measure from this study; vascular cell adhesion molecule-(VCAM-1), nitric oxide (NO) and malonyldialdehyde (MDA). The outcome measure will be assessed at three times; before soy isoflavone supplementation / the beginning of study,post supplementation 6 months and 12 months. The outcome will be measured change from baseline in the level of VCAM-1, NO and MDA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| soy isoflavone 100 mg | Experimental | the experimental group receiving tablet contain soy isoflavone 100 mg and calcium carbonate 500 mg |
|
| calcium carbonate 500 mg | Placebo Comparator | The control group receiving a tablet contains calcium carbonate 500 mg for 6 months and 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soy isoflavone | Dietary Supplement | 100 mg soy isoflavone tablet containing genistein 55%, daidzein 39% and glycitein 6% and calcium carbonate 500 mg in the experimental group for 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| the changes levels of endothelial function marker in blood after 13 months supplementation | this study were measured the change levels of vascular cell adhesion molecule-1 (VCAM-1), nitric oxide (NO) as endothelial function parameter and malonyldialdehide as lipid peroxidation parameter from baseline to 6 months supplementation and from baseline to 13 months supplementation | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| the changes levels of osteoporosis parameter after 6 months supplementation | This study have another outcome such as rank ligand, C telopeptide and osteoprotegrin as marker of osteoporosis. We will be measured the changes levels of osteoporosis marker after 6 months supplementation | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pusparini Sunarno, Doctor | Trisakti University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trisakti University | Jakarta | DKI Jakarta | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Hall WL, Rimbach G, Williams CM. isoflavones and endothelial function. Nutrion Research Review 18:123-131, 2005. Vincent A,Fitzpatrick LA. soy Isoflavone: are they useful in menopause? Mayo clinic Proceeding 75:1171-1184, 2000 |
| Label | URL |
|---|---|
| click here for more information about this tudy | View source |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D030262 | Soybean Proteins |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D010940 | Plant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014674 | Plant Proteins, Dietary |
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|
| control group | Dietary Supplement | the control group receiving tablet contain calcium carbonate 500 mg/day for 6 months and 12 months |
|
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D004044 |
| Dietary Proteins |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
| D019602 | Food and Beverages |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |