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Green tea polyphenols and Tai Chi exercise for postmenopausal osteopenic women: safety report from a 24‐week placebo‐controlled randomized trial
Author(s) -
Shen ChwanLi,
Chyu MingChien,
Yeh James K,
Zhang Yan,
Pence Barbara C,
Felton Carol K,
Dagda Raul Y,
Dagda Marisela,
Doctolero Susan,
Flores Mary J,
Wang JiaSheng
Publication year - 2010
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.24.1_supplement.946.8
Subject(s) - medicine , placebo , creatinine , adverse effect , liver function , randomized controlled trial , osteopenia , blood urea nitrogen , endocrinology , osteoporosis , physical therapy , bone mineral , alternative medicine , pathology
Osteoporosis is a major health problem in postmenopausal women. This study was to evaluate the effects of 24‐week green tea polyphenols supplementation (GTP) along with Tai Chi exercise (TC) on safety. 171 postmenopausal women with osteopenia (57.4±6.8 yr, BMI 28.4±5.3 kg/m 2 ) were assigned to 4 treatment: placebo (500 mg starch/d), GTP (500 mg GTP/d), placebo+TC (60 min TC/session, 3×/wk), and GTP+TC for 24 weeks. Laboratory blood chemistry parameters including liver function (aspartate aminotransferase, AST and alanine aminotransferase, ALT), alkaline phosphates, total bilirubin, urea nitrogen, calcium, inorganic phosphorus, and creatinine were assessed in overnight fasting blood samples taken at baseline and every 4 weeks throughout the study period. Data was analyzed by two‐way ANOVA. After 24 weeks intervention, 21 participants dropped out (12% attrition rate) due to loss of interest or any other condition unrelated to the current study intervention. The compliance rates for study agent and TC exercise were 89% and 83%, respectively. Neither GTP supplementation nor TC exercise affected liver function, as determined by AST and ALT laboratory results. Similarly, other blood chemistry parameters were not affected by any treatment throughout the study. No adverse event due to study treatment was reported by the participants, regardless of group assignment. These data demonstrated that GTP supplementation at 500 mg daily and TC exercise for 24 weeks was considered a safe approach to postmenopausal women with low bone mass. Study was supported by NCCAM/NIH R21AT003735 (CLS).