Green Tea and Tai Chi for Bone Health - Full Text View

Sponsor:	Texas Tech University Health Sciences Center
Collaborator:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	Texas Tech University Health Sciences Center
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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	GTP and Tai Chi for Bone Health: a Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Exercise and Physical Fitness Osteoporosis

U.S. FDA Resources

Further study details as provided by Texas Tech University Health Sciences Center:

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
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

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

Locations

United States, Texas
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430

Sponsors and Collaborators

Texas Tech University Health Sciences Center

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Chwan-Li (Leslie) Shen, PhD

Texas Tech University Health Sciences Center

More Information

Publications:

Shen CL, Wang P, Guerrieri J, Yeh JK, Wang JS. Protective effect of green tea polyphenols on bone loss in middle-aged female rats. Osteoporos Int. 2007 Dec 15; [Epub ahead of print]

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Responsible Party:	Shen, Chwan-Li/Assistant Professor of Pathology, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00625391 History of Changes
Other Study ID Numbers:	R21 AT003735-01A1, R21AT003735-01A1
Study First Received:	February 26, 2008
Last Updated:	March 17, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Texas Tech University Health Sciences Center:

postmenopausal, bone, dietary supplement, mind-body exercise

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on February 13, 2012