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NCT00625391 · ClinicalTrials.gov registry record · Phase 1
Green Tea and Tai Chi for Bone Health
A Phase 1 study, sponsored by Texas Tech University Health Sciences Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 171
- Enrollment target
NCT00625391: Completed Phase 1 study, sponsored by Texas Tech University Health Sciences Center.
NCT00625391 is a Phase 1 study that has completed, run by Texas Tech University Health Sciences Center. The registered enrollment target is 171 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (185% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00625391, a Phase 1 study, has completed, sponsored by Texas Tech University Health Sciences Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 171 participants
- Enrollment target
Study 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.
Primary Outcome
Bone formation biomarker: bone-specific alkaline phosphatase (BAP) Bone resorption biomarker: tartrate-resistant acid phosphatase (TRAP)
Interventions
- DRUG Placebo
- DRUG Green Tea Polyphenols (GTP)
- DRUG Placebo+Tai Chi (TC)
- DRUG GTP+TC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2008-02 |
| Est. Completion | 2009-08 |
| Phase | Phase 1 |
What the finished NCT00625391 record still lists
NCT00625391 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (185% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00625391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00625391 about?
NCT00625391 is a clinical study titled "Green Tea and Tai Chi for Bone Health". 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 d...
What is the current status of trial NCT00625391?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 171 participants. The study started on 2008-02. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00625391?
The interventions under investigation include: Placebo (DRUG), Green Tea Polyphenols (GTP) (DRUG), Placebo+Tai Chi (TC) (DRUG), GTP+TC (DRUG).
Who is sponsoring clinical trial NCT00625391?
This trial is sponsored by Texas Tech University Health Sciences Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00625391's enrollment target sits among peer trials
171 324th of 2000 higher than 1,676 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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