Green Tea and Tai Chi for Bone Health (GTP-TC-Bone)
August 1, 2014 updated by: Leslie Shen, Texas Tech University Health Sciences Center
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 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
171
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Lubbock, Texas, United States, 79430
- Texas Tech University Health Sciences Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo pill
24 weeks of placebo.
|
500 mg medicinal starch pills daily
Other Names:
|
|
Active Comparator: Green Tea Polyphenols (GTP)
24 weeks of green tea polyphenols
|
500 mg green tea polyphenols daily
Other Names:
|
|
Active Comparator: Placebo+Tai Chi (TC)
24 weeks of placebo plus Tai Chi exercise.
|
500 mg medicinal starch daily and Tai Chi (3x/week) for 24 weeks
Other Names:
|
|
Active Comparator: GTP+TC
24 weeks of green tea polyphenols plus Tai Chi exercise.
|
500 mg GTP daily plus TC exercise (3x/week) for 24 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker
Time Frame: 24 weeks
|
Bone formation biomarker: bone-specific alkaline phosphatase (BAP) Bone resorption biomarker: tartrate-resistant acid phosphatase (TRAP)
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxidative Stress Damage Biomarker
Time Frame: 24 weeks
|
Oxidative stress damage biomarker: urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG) test
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chwan-Li (Leslie) Shen, PhD, Texas Tech University Health Sciences Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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. Erratum In: Nutr Res. 2009 Sep;29(9):684.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
February 26, 2008
First Submitted That Met QC Criteria
February 26, 2008
First Posted (Estimate)
February 28, 2008
Study Record Updates
Last Update Posted (Estimate)
August 18, 2014
Last Update Submitted That Met QC Criteria
August 1, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT003735-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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