Clinical trial NCT00625391: Green Tea and Tai Chi for Bone Health
Official title: GTP and Tai Chi for Bone Health: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoporosis
Keywords: postmenopausal, bone, dietary supplement, mind-body exercise
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2008-02-28
Enrollment: 171
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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, 4, 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. Additional secondary outcome is muscle strength/physical function. Investigators evaluating the endpoints will be blinded to intervention allocation.

Eligibility criteria: 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.
* 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.

Primary outcomes:
measure: Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker
timeFrame: 24 weeks
Secondary outcomes:
measure: Oxidative Stress Damage Biomarker
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Chwan-Li (Leslie) Shen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1186/1471-2474-10-110.
citation: Shen CL, Yeh JK, Cao JJ, Chyu MC, Wang JS. Green tea and bone health: Evidence from laboratory studies. Pharmacol Res. 2011 Aug;64(2):155-61. doi: 10.1016/j.phrs.2011.03.012. Epub 2011 Apr 5.
citation: Shen CL, Yeh JK, Cao JJ, Wang JS. Green tea and bone metabolism. Nutr Res. 2009 Jul;29(7):437-56. doi: 10.1016/j.nutres.2009.06.008.
citation: Shen CL, Chyu MC, Wang JS. Tea and bone health: steps forward in translational nutrition. Am J Clin Nutr. 2013 Dec;98(6 Suppl):1694S-1699S. doi: 10.3945/ajcn.113.058255. Epub 2013 Oct 30.
citation: Shen CL, Chyu MC, Yeh JK, Zhang Y, Pence BC, Felton CK, Brismee JM, Arjmandi BH, Doctolero S, Wang JS. Effect of green tea and Tai Chi on bone health in postmenopausal osteopenic women: a 6-month randomized placebo-controlled trial. Osteoporos Int. 2012 May;23(5):1541-52. doi: 10.1007/s00198-011-1731-x. Epub 2011 Jul 16.
citation: Shen CL, Chyu MC, Pence BC, Yeh JK, Zhang Y, Felton CK, Doctolero S, Wang JS. Green tea polyphenols supplementation and Tai Chi exercise for postmenopausal osteopenic women: safety and quality of life report. BMC Complement Altern Med. 2010 Dec 9;10:76. doi: 10.1186/1472-6882-10-76.
citation: Qian G, Xue K, Tang L, Wang F, Song X, Chyu MC, Pence BC, Shen CL, Wang JS. Mitigation of oxidative damage by green tea polyphenols and Tai Chi exercise in postmenopausal women with osteopenia. PLoS One. 2012;7(10):e48090. doi: 10.1371/journal.pone.0048090. Epub 2012 Oct 31.