| February 26, 2008 |
| February 26, 2008 |
| February 2008 |
| August 2009 (final data collection date for primary outcome measure) |
| attrition rate, compliance [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ] |
| Same as current |
| No Changes Posted |
| bone turnover biomarkers, oxidative stress damage biomarker, biomechanical response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Green Tea and Tai Chi for Bone Health |
| GTP and Tai Chi for Bone Health: a Pilot Study |
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, biomechanical responses, and bone microstructure in postmenopausal women with osteopenia compared to those receiving placebo only, and (2) the changes in bone biomarkers and bone microstructure 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, 6, 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. Investigators evaluating the endpoints will be blinded to intervention allocation. |
| Phase I, Phase II |
| Interventional |
| Prevention, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
| Osteoporosis |
- Other: placebo
- Dietary Supplement: GTP
- Behavioral: Placebo plus Tai Chi
- Other: GTP plus Tai Chi
|
- Placebo Comparator: 24 weeks of placebo.
- Active Comparator: 24 weeks of green tea polyphenols
- Active Comparator: 24 weeks of placebo plus Tai Chi exercise.
- Active Comparator: 24 weeks of green tea polyphenols plus Tai Chi exercise.
|
- Shen CL, Wang P, Guerrieri J, Yeh JK, Wang JS. Protective effect of green tea polyphenols on bone loss in middle-aged female rats. Osteoporos Int. 2007 Dec 15; [Epub ahead of print]
- 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.
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| |
| Recruiting |
| 200 |
| August 2009 |
| August 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Women at least 2 years after menopause (to ensure established postmenopausal status).
- Sedentary at baseline.
- Normal laboratory evaluation, thyroid function, hepatic function, renal function.
- Osteopenia.
Exclusion Criteria:
- History of scoliosis, severe osteoarthritis, etc., or other spinal disease that may result in anatomy unsuitable for accurate bone densitometry.
- History of cancer with some exceptions.
- History of metabolic bone disease.
- Beginning a regimen of any estrogen recently.
- Having used anabolic steroids, calcitonin, calcitriol, alfacalcidol, etc.
- Fluoride treatment at a dose greater than 1 mg/day any time.
- History of glucocorticoid treatment.
- Any previous treatment with bisphosphonates.
- Uncontrolled intercurrent illness such as symptomatic congestive heart failure, myocardial infarction or stroke, hypertension, or terminal illness.
- Physical conditions that preclude participation of exercise intervention.
- Cognitive impairment.
- Depression.
- History of malabsorption syndrome and uncontrolled diabetes mellitus.
|
| Female |
|
| Yes |
|
|
| United States |
| |
| NCT00625391 |
| Shen, Chwan-Li/Assistant Professor of Pathology, Texas Tech University Health Sciences Center |
| R21 AT003735-01A1 |
| National Center for Complementary and Alternative Medicine (NCCAM) |
|
| Principal Investigator: |
Chwan-Li (Leslie) Shen, PhD |
Texas Tech University Health Sciences Center |
|
|
| National Center for Complementary and Alternative Medicine (NCCAM) |
| February 2008 |