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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT003735-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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Osteoporosis is a major health problem in postmenopausal women. Our long-term goal is to develop a new alternative treatment that include a dietary supplement (green tea extract) and a mind-body exercise (Tai Chi) for lessening bone loss in postmenopausal women with low bone mass. A combination of dietary supplement and moderate intensity exercise now becomes a new alternative treatment in reducing bone loss in postmenopausal women with low bone mass, due to the possible stronger effects of the combination than individual treatments. Objective: To test a CAM intervention including green tea polyphenol (GTP) and Tai Chi (TC) exercise for feasibility, and to quantitatively assess their individual and conjugate effects on postmenopausal women with osteopenia. Hypotheses: (1) 24 weeks of GTP supplement, TC exercise, and their combination will benefit bone remodeling as measured by bone biomarkers and muscle strength/physical function in postmenopausal women with osteopenia compared to those receiving placebo only, and (2) the changes in bone biomarkers associated with bone remodeling will be correlated with the changes in oxidative stress.
This is a 24-week, randomized, and placebo-controlled intervention trial to investigate the effects of green tea polyphenols (GTP) and Tai Chi (TC) on relevant primary and secondary endpoints in postmenopausal women with osteopenia. Women at least 2 years after menopause, with osteopenia, will be recruited primarily from local senior independent/assisted living facilities, municipal senior community centers, and obstetrics and gynecology clinics. After screening, qualified participants will be matched for age and will be randomly assigned to one of the four treatment groups: placebo, GTP, placebo+TC, and GTP+TC. During the 24-week intervention, all participants will be provided with calcium and vitamin D daily. The participants in the placebo group will receive medicinal starch for 24 weeks. The GTP participants will receive GTP for 24 weeks. The placebo+TC participants will receive both placebo and TC treatments for 24 weeks. The GTP+TC participants will receive both GTP and TC treatments for 24 weeks. Participants will receive the primary and secondary outcome measures at baseline, 4, 12, and 24 weeks. The primary outcome measures are concentrations of bone biomarkers. The secondary outcome measure is a biomarker of oxidative stress DNA damage. Additional secondary outcome is muscle strength/physical function. Investigators evaluating the endpoints will be blinded to intervention allocation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo pill | Placebo Comparator | 24 weeks of placebo. |
|
| Green Tea Polyphenols (GTP) | Active Comparator | 24 weeks of green tea polyphenols |
|
| Placebo+Tai Chi (TC) | Active Comparator | 24 weeks of placebo plus Tai Chi exercise. |
|
| GTP+TC | Active Comparator | 24 weeks of green tea polyphenols plus Tai Chi exercise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 500 mg medicinal starch pills daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker | Bone formation biomarker: bone-specific alkaline phosphatase (BAP) Bone resorption biomarker: tartrate-resistant acid phosphatase (TRAP) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Oxidative Stress Damage Biomarker | Oxidative stress damage biomarker: urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG) test | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chwan-Li (Leslie) Shen, PhD | Texas Tech University Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Tech University Health Sciences Center | Lubbock | Texas | 79430 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19732445 | Background | Shen CL, Chyu MC, Yeh JK, Felton CK, Xu KT, Pence BC, Wang JS. Green tea polyphenols and Tai Chi for bone health: designing a placebo-controlled randomized trial. BMC Musculoskelet Disord. 2009 Sep 4;10:110. doi: 10.1186/1471-2474-10-110. | |
| 21473914 | Background | Shen CL, Yeh JK, Cao JJ, Chyu MC, Wang JS. Green tea and bone health: Evidence from laboratory studies. Pharmacol Res. 2011 Aug;64(2):155-61. doi: 10.1016/j.phrs.2011.03.012. Epub 2011 Apr 5. |
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There was no any significant events arranged.
Recruitment period: March 2008 - December 2008. Location: community setting
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Group | Placebo group receiving 500 mg medicinal starch daily for 24 weeks. |
| FG001 | Green Tea Polyphenols (GTP) Group | Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks. |
| FG002 | Placebo + Tai Chi Group | Placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks. |
| FG003 | GTP + Tai Chi Group | GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo group receiving 500 mg medicinal starch daily for 24 weeks. |
| BG001 | Green Tea Polyphenols (GTP) | Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker | Bone formation biomarker: bone-specific alkaline phosphatase (BAP) Bone resorption biomarker: tartrate-resistant acid phosphatase (TRAP) | Analyzed on those who completed the study. Percent change relative to the baseline for each group. | Posted | Mean | Standard Deviation | percentage change from baseline | 24 weeks |
|
24 weeks during the study period.
Total number of participants at risk "serious and other [Non-serious] adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Medicinal starch at 500 mg daily for 24 weeks |
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Limitation of this study included: (1) the number of subjects in each group at the baseline was not equal. (2) The amount of dietary calcium intake for each subject was not available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chwan-Li Shen | Texas Tech University Health Sciences Center | (806) 743-2815 | Leslie.Shen@ttuhsc.edu |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D013662 | Tea |
| D020830 | rac1 GTP-Binding Protein |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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| Green Tea Polyphenols (GTP) | Drug | 500 mg green tea polyphenols daily |
|
|
| Placebo+Tai Chi (TC) | Drug | 500 mg medicinal starch daily and Tai Chi (3x/week) for 24 weeks |
|
|
| GTP+TC | Drug | 500 mg GTP daily plus TC exercise (3x/week) for 24 weeks |
|
|
| 19700031 | Background | Shen CL, Yeh JK, Cao JJ, Wang JS. Green tea and bone metabolism. Nutr Res. 2009 Jul;29(7):437-56. doi: 10.1016/j.nutres.2009.06.008. |
| 24172296 | Background | Shen CL, Chyu MC, Wang JS. Tea and bone health: steps forward in translational nutrition. Am J Clin Nutr. 2013 Dec;98(6 Suppl):1694S-1699S. doi: 10.3945/ajcn.113.058255. Epub 2013 Oct 30. |
| 21766228 | Result | Shen CL, Chyu MC, Yeh JK, Zhang Y, Pence BC, Felton CK, Brismee JM, Arjmandi BH, Doctolero S, Wang JS. Effect of green tea and Tai Chi on bone health in postmenopausal osteopenic women: a 6-month randomized placebo-controlled trial. Osteoporos Int. 2012 May;23(5):1541-52. doi: 10.1007/s00198-011-1731-x. Epub 2011 Jul 16. |
| 21143878 | Result | Shen CL, Chyu MC, Pence BC, Yeh JK, Zhang Y, Felton CK, Doctolero S, Wang JS. Green tea polyphenols supplementation and Tai Chi exercise for postmenopausal osteopenic women: safety and quality of life report. BMC Complement Altern Med. 2010 Dec 9;10:76. doi: 10.1186/1472-6882-10-76. |
| 23118932 | Result | Qian G, Xue K, Tang L, Wang F, Song X, Chyu MC, Pence BC, Shen CL, Wang JS. Mitigation of oxidative damage by green tea polyphenols and Tai Chi exercise in postmenopausal women with osteopenia. PLoS One. 2012;7(10):e48090. doi: 10.1371/journal.pone.0048090. Epub 2012 Oct 31. |
| BG002 | Placebo+Tai Chi | Placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks. |
| BG003 | GTP+Tai Chi | GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Green Tea Polyphenols |
GTP group receiving 500 mg green tea polyphenols daily for 24 weeks |
| OG002 | Placebo + Tai Chi | Placebo + Tai Chi: receiving 500 mg medicinal starch daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks |
| OG003 | Green Tea Polyphenol + Tai Chi | GTP + Tai Chi: receiving 500 mg green tea polyphenols daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks. |
|
|
| Secondary | Oxidative Stress Damage Biomarker | Oxidative stress damage biomarker: urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG) test | Analyzed who completed the study. | Posted | Mean | Standard Deviation | ng/mg creatinine | 24 weeks |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Green Tea Polyphenols (GTP) | Green tea polyphenols at 500 mg daily for 24 weeks | 0 | 39 | 0 | 39 |
| EG002 | Placebo+Tai Chi (TC) | Medicinal starch at 500 mg daily and Tai Chi group exercise at 1 hour/session x 3 sessions/week for 24 weeks | 0 | 37 | 0 | 37 |
| EG003 | GTP+TC | Green tea polyphenols at 500 mg daily and Tai Chi group exercise at 1 hour/session x 3 sessions/week for 24 weeks | 0 | 37 | 0 | 37 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D020744 | rac GTP-Binding Proteins |
| D020741 | rho GTP-Binding Proteins |
| D020559 | Monomeric GTP-Binding Proteins |
| D019204 | GTP-Binding Proteins |
| D020558 | GTP Phosphohydrolases |
| D017766 | Acid Anhydride Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D047908 | Intracellular Signaling Peptides and Proteins |