Green Tea and Tai Chi for Bone Health
GTP-TC-Bone
GTP and Tai Chi for Bone Health: a Pilot Study
1 other identifier
interventional
171
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 26, 2008
CompletedFirst Posted
Study publicly available on registry
February 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
August 18, 2014
CompletedAugust 18, 2014
August 1, 2014
1.5 years
February 26, 2008
December 5, 2012
August 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker
Bone formation biomarker: bone-specific alkaline phosphatase (BAP) Bone resorption biomarker: tartrate-resistant acid phosphatase (TRAP)
24 weeks
Secondary Outcomes (1)
Oxidative Stress Damage Biomarker
24 weeks
Study Arms (4)
Placebo pill
PLACEBO COMPARATOR24 weeks of placebo.
Green Tea Polyphenols (GTP)
ACTIVE COMPARATOR24 weeks of green tea polyphenols
Placebo+Tai Chi (TC)
ACTIVE COMPARATOR24 weeks of placebo plus Tai Chi exercise.
GTP+TC
ACTIVE COMPARATOR24 weeks of green tea polyphenols plus Tai Chi exercise.
Interventions
500 mg green tea polyphenols daily
500 mg medicinal starch daily and Tai Chi (3x/week) for 24 weeks
500 mg GTP daily plus TC exercise (3x/week) for 24 weeks
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430, United States
Related Publications (7)
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.
PMID: 19732445BACKGROUNDShen 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.
PMID: 21473914BACKGROUNDShen 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.
PMID: 19700031BACKGROUNDShen 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.
PMID: 24172296BACKGROUNDShen 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.
PMID: 21766228RESULTShen 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.
PMID: 21143878RESULTQian 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.
PMID: 23118932RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Limitation of this study included: (1) the number of subjects in each group at the baseline was not equal. (2) The amount of dietary calcium intake for each subject was not available.
Results Point of Contact
- Title
- Dr. Chwan-Li Shen
- Organization
- Texas Tech University Health Sciences Center
Study Officials
- PRINCIPAL INVESTIGATOR
Chwan-Li (Leslie) Shen, PhD
Texas Tech University Health Sciences Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 26, 2008
First Posted
February 28, 2008
Study Start
February 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
August 18, 2014
Results First Posted
August 18, 2014
Record last verified: 2014-08