Green Tea and Tai Chi for Bone Health
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Osteoporosis
In brief
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.
Key facts
- Study ID
- NCT00625391
- Run by
- Texas Tech University Health Sciences Center
- People needed
- 171
- Starts
- 2008-02-01
- Expected to finish
- 2009-08-01
- Last updated by the study team
- 2014-08-18
Who can join
Age: any. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- 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.
Where it is running
- Texas Tech University Health Sciences Center — Lubbock, Texas, United States
Full record on ClinicalTrials.gov
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