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

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ClinicalTrials.gov Identifier: NCT00625391
Recruitment Status : Completed
First Posted : February 28, 2008
Results First Posted : August 18, 2014
Last Update Posted : August 18, 2014
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Leslie Shen, Texas Tech University Health Sciences Center

Tracking Information
First Submitted Date  ICMJE February 26, 2008
First Posted Date  ICMJE February 28, 2008
Results First Submitted Date  ICMJE December 5, 2012
Results First Posted Date  ICMJE August 18, 2014
Last Update Posted Date August 18, 2014
Study Start Date  ICMJE February 2008
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2014)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2008)
attrition rate, compliance [ Time Frame: 24 weeks ]
Change History Complete list of historical versions of study NCT00625391 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2014)
Oxidative Stress Damage Biomarker [ Time Frame: 24 weeks ]
Oxidative stress damage biomarker: urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG) test
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2008)
bone turnover biomarkers, oxidative stress damage biomarker, biomechanical response [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Green Tea and Tai Chi for Bone Health
Official Title  ICMJE GTP and Tai Chi for Bone Health: a Pilot Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Osteoporosis
Intervention  ICMJE
  • Drug: Placebo
    500 mg medicinal starch pills daily
    Other Name: Placebo control group
  • Drug: Green Tea Polyphenols (GTP)
    500 mg green tea polyphenols daily
    Other Name: Green tea polyphenols group
  • Drug: Placebo+Tai Chi (TC)
    500 mg medicinal starch daily and Tai Chi (3x/week) for 24 weeks
    Other Name: Placebo plus tai chi exercise group
  • Drug: GTP+TC
    500 mg GTP daily plus TC exercise (3x/week) for 24 weeks
    Other Name: Green tea polyphenols plus tai chi exercise group
Study Arms  ICMJE
  • Placebo Comparator: Placebo pill
    24 weeks of placebo.
    Intervention: Drug: Placebo
  • Active Comparator: Green Tea Polyphenols (GTP)
    24 weeks of green tea polyphenols
    Intervention: Drug: Green Tea Polyphenols (GTP)
  • Active Comparator: Placebo+Tai Chi (TC)
    24 weeks of placebo plus Tai Chi exercise.
    Intervention: Drug: Placebo+Tai Chi (TC)
  • Active Comparator: GTP+TC
    24 weeks of green tea polyphenols plus Tai Chi exercise.
    Intervention: Drug: GTP+TC
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 5, 2012)
171
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2008)
200
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00625391
Other Study ID Numbers  ICMJE R21AT003735-01A1( U.S. NIH Grant/Contract )
R21AT003735-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Leslie Shen, Texas Tech University Health Sciences Center
Study Sponsor  ICMJE Texas Tech University Health Sciences Center
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Chwan-Li (Leslie) Shen, PhD Texas Tech University Health Sciences Center
PRS Account Texas Tech University Health Sciences Center
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP