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Green Tea and Tai Chi for Bone Health (GTP-TC-Bone)

This study is currently recruiting participants.
Verified by National Center for Complementary and Alternative Medicine (NCCAM), February 2008

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00625391
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Other: placebo
Dietary Supplement: GTP
Behavioral: Placebo plus Tai Chi
Other: GTP plus Tai Chi
Phase I
Phase II

MedlinePlus related topics:   Dietary Supplements    Exercise and Physical Fitness    Osteoporosis   

ChemIDplus related topics:   Starch   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title:   GTP and Tai Chi for Bone Health: a Pilot Study

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • attrition rate, compliance [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • bone turnover biomarkers, oxidative stress damage biomarker, biomechanical response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:   200
Study Start Date:   February 2008
Estimated Study Completion Date:   August 2009
Estimated Primary Completion Date:   August 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Placebo Comparator
24 weeks of placebo.
Other: placebo
24 weeks of medical starch placebo.
2: Active Comparator
24 weeks of green tea polyphenols
Dietary Supplement: GTP
24 weeks of green tea polyphenols (GTP).
3: Active Comparator
24 weeks of placebo plus Tai Chi exercise.
Behavioral: Placebo plus Tai Chi
24 weeks of medical starch plus Tai Chi exercise.
4: Active Comparator
24 weeks of green tea polyphenols plus Tai Chi exercise.
Other: GTP plus Tai Chi
24 weeks of green tea polyphenols plus Tai Chi intervention.

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, 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.

  Eligibility
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
  • 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625391

Contacts
Contact: Susan Doctolero, CCRN, CCRC     (806) 743-4222 ext 310     Susan.Doctolero@ttuhsc.edu    

Locations
United States, Texas
Texas Tech University Health Sciences Center     Recruiting
      Lubbock, Texas, United States, 79430
      Contact: Susan Doctolero, CCRN, CCRC     806-743-4222 ext 310     Susan.Doctolero@ttuhsc.edu    
      Contact: , RN            
      Principal Investigator: Chwan-Li (Leslie) Shen, PhD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Chwan-Li (Leslie) Shen, PhD     Texas Tech University Health Sciences Center    
  More Information

Publications:

Responsible Party:   Texas Tech University Health Sciences Center ( Shen, Chwan-Li/Assistant Professor of Pathology )
Study ID Numbers:   R21 AT003735-01A1
First Received:   February 26, 2008
Last Updated:   February 26, 2008
ClinicalTrials.gov Identifier:   NCT00625391
Health Authority:   United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
postmenopausal, bone, dietary supplement, mind-body exercise  

Study placed in the following topic categories:
Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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