GTP and Tai Chi for Bone Health: a Pilot Study

描述（由申请人提供）：骨质疏松症是绝经后妇女的主要健康问题。我们的长期目标是开发一种新的补充和替代医学（CAM）策略，以饮食补充和身心锻炼为特色，减轻绝经后低骨量妇女的骨质流失。目的：探讨绿茶多酚（GTP）与太极（TC）运动联合干预绝经后骨质减少症的可行性，并定量评价其对绝经后骨质减少症的个体和联合作用。假设：(1)与仅接受安慰剂的绝经后骨质减少妇女相比，24周的GTP补充，TC运动及其组合将有利于骨重塑，(2)与骨重塑相关的骨生物标志物的变化将与氧化应激的变化相关。具体目标是：

DESCRIPTION (provided by applicant): 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.