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| 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 |
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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 |
| 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 |
| 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 |
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1: Placebo Comparator
24 weeks of placebo.
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Other: placebo
24 weeks of medical starch placebo.
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2: Active Comparator
24 weeks of green tea polyphenols
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Dietary Supplement: GTP
24 weeks of green tea polyphenols (GTP).
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3: Active Comparator
24 weeks of placebo plus Tai Chi exercise.
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Behavioral: Placebo plus Tai Chi
24 weeks of medical starch plus Tai Chi exercise.
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4: Active Comparator
24 weeks of green tea polyphenols plus Tai Chi exercise.
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Other: GTP plus Tai Chi
24 weeks of green tea polyphenols plus Tai Chi intervention.
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Susan Doctolero, CCRN, CCRC | (806) 743-4222 ext 310 | Susan.Doctolero@ttuhsc.edu |
| 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 | |||||
| Principal Investigator: | Chwan-Li (Leslie) Shen, PhD | Texas Tech University Health Sciences Center |
More Information
| 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 |
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