Osteoporosis is a major health problem in postmenopausal women. Our long-term goal is to develop a new complementary and alternative medicine (CAM) strategy featuring a dietary supplement and a mind-body exercise for alleviating bone loss in postmenopausal women with low bone mass. 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 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.
The specific aims are: ? 1. To perform a 24-week randomized and placebo-controlled intervention trial in 140 postmenopausal women with osteopenia. Study participants will be assigned to 4 treatment arms: (1) placebo control group receiving medicinal starch pills daily, (2) GTP group receiving 1000 mg of GTP per day, (3) placebo+TC group receiving both placebo treatment and TC training (60-minute group exercise, 3 times per week), and (4) GTP+TC group receiving both GTP and TC treatments for 24 weeks. During the intervention, all participants will be provided with 1000 mg of elemental calcium and 400 IU of vitamin D daily. We will evaluate accrual rate, retention and compliance, adverse events, delivery of the intervention, appropriateness of inclusion/exclusion criteria, and optimization of the overall protocol design for the planned clinical trial. ? 2. To evaluate the effects of GTP, TC and their combined interventions on bone turnover and DNA damage oxidative stress biomarkers at baseline, 6, 12 and 24 wks. The bone turnover biomarkers will include bone formation biomarker (serum bone alkaline phosphatase) and bone resorption biomarker (urinary type I collagen cross-linked N-(NTX)). The oxidative DNA damage biomarker will be 8-hydroxy-2'- deoxyguanosine (8-OHdG) in urine. A model of repeated measurements with random effect error terms will be applied. Traditional procedures such as ANCOVA, chi-squared analysis, regression, and bivariate correlation will also be used for comparisons. ? Significance: The study will result in a new alternative rehabilitation treatment with proven anti-osteoporotic benefits for postmenopausal women with low bone mass. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21AT003735-01A1
Application #
7256775
Study Section
Special Emphasis Panel (ZAT1-JH (18))
Program Officer
Khalsa, Partap Singh
Project Start
2007-09-01
Project End
2009-08-31
Budget Start
2007-09-01
Budget End
2008-08-31
Support Year
1
Fiscal Year
2007
Total Cost
$328,303
Indirect Cost
Name
Texas Tech University
Department
Pathology
Type
Schools of Medicine
DUNS #
609980727
City
Lubbock
State
TX
Country
United States
Zip Code
79430
Shen, Chwan-Li; Chyu, Ming-Chien (2016) Tea flavonoids for bone health: from animals to humans. J Investig Med 64:1151-7
Shen, Chwan-Li; Kwun, In-Sook; Wang, Shu et al. (2013) Functions and mechanisms of green tea catechins in regulating bone remodeling. Curr Drug Targets 14:1619-30
Shen, Chwan-Li; Chyu, Ming-Chien; Wang, Jia-Sheng (2013) Tea and bone health: steps forward in translational nutrition. Am J Clin Nutr 98:1694S-1699S
Qian, Guoqing; Xue, Kathy; Tang, Lili et al. (2012) Mitigation of oxidative damage by green tea polyphenols and Tai Chi exercise in postmenopausal women with osteopenia. PLoS One 7:e48090
Shen, C-L; Chyu, M-C; Yeh, J K et al. (2012) Effect of green tea and Tai Chi on bone health in postmenopausal osteopenic women: a 6-month randomized placebo-controlled trial. Osteoporos Int 23:1541-52
Shen, Chwan-Li; Yeh, James K; Cao, Jay J et al. (2011) Green tea and bone health: Evidence from laboratory studies. Pharmacol Res 64:155-61
Shen, C-L; Yeh, J K; Samathanam, C et al. (2011) Green tea polyphenols attenuate deterioration of bone microarchitecture in female rats with systemic chronic inflammation. Osteoporos Int 22:327-37
Shen, C-L; Yeh, J K; Cao, J J et al. (2010) Synergistic effects of green tea polyphenols and alphacalcidol on chronic inflammation-induced bone loss in female rats. Osteoporos Int 21:1841-52
Shen, Chwan-Li; Yeh, James K; Cao, Jay J et al. (2010) Green tea polyphenols mitigate bone loss of female rats in a chronic inflammation-induced bone loss model. J Nutr Biochem 21:968-74
Shen, Chwan-Li; Chyu, Ming-Chien; Pence, Barbara C et al. (2010) Green tea polyphenols supplementation and Tai Chi exercise for postmenopausal osteopenic women: safety and quality of life report. BMC Complement Altern Med 10:76

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