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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Osteoporosis
Interventions Drug: Placebo
Drug: Green Tea Polyphenols (GTP)
Drug: Placebo+Tai Chi (TC)
Drug: GTP+TC
Enrollment 171
Recruitment Details Recruitment period: March 2008 - December 2008. Location: community setting
Pre-assignment Details There was no any significant events arranged.
Arm/Group Title Placebo Group Green Tea Polyphenols (GTP) Group Placebo + Tai Chi Group GTP + Tai Chi Group
Hide Arm/Group Description Placebo group receiving 500 mg medicinal starch daily for 24 weeks. Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks. Placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks. GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks.
Period Title: Overall Study
Started 44 47 42 38
Completed 37 39 37 37
Not Completed 7 8 5 1
Arm/Group Title Placebo Green Tea Polyphenols (GTP) Placebo+Tai Chi GTP+Tai Chi Total
Hide Arm/Group Description Placebo group receiving 500 mg medicinal starch daily for 24 weeks. Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks. Placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks. GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 44 47 42 38 171
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 47 participants 42 participants 38 participants 171 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
38
  86.4%
42
  89.4%
36
  85.7%
33
  86.8%
149
  87.1%
>=65 years
6
  13.6%
5
  10.6%
6
  14.3%
5
  13.2%
22
  12.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 47 participants 42 participants 38 participants 171 participants
57.6  (7.5) 56.5  (5.5) 58.3  (7.7) 57.6  (6.7) 57.4  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 47 participants 42 participants 38 participants 171 participants
Female
44
 100.0%
47
 100.0%
42
 100.0%
38
 100.0%
171
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants 47 participants 42 participants 38 participants 171 participants
44 47 42 38 171
1.Primary Outcome
Title Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker
Hide Description Bone formation biomarker: bone-specific alkaline phosphatase (BAP) Bone resorption biomarker: tartrate-resistant acid phosphatase (TRAP)
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed on those who completed the study. Percent change relative to the baseline for each group.
Arm/Group Title Placebo Green Tea Polyphenols Placebo + Tai Chi Green Tea Polyphenol + Tai Chi
Hide Arm/Group Description:

Placebo group receiving 500 mg medicinal starch daily for 24 weeks.

Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.

placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.

GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks.

GTP group receiving 500 mg green tea polyphenols daily for 24 weeks
Placebo + Tai Chi: receiving 500 mg medicinal starch daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks
GTP + Tai Chi: receiving 500 mg green tea polyphenols daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks.
Overall Number of Participants Analyzed 37 39 37 37
Mean (Standard Deviation)
Unit of Measure: percentage change from baseline
106.1  (3.7) 103.6  (2.9) 112.3  (3.0) 113.0  (3.0)
2.Secondary Outcome
Title Oxidative Stress Damage Biomarker
Hide Description Oxidative stress damage biomarker: urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG) test
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed who completed the study.
Arm/Group Title Placebo Green Tea Polyphenols Placebo + Tai Chi Green Tea Polyphenol + Tai Chi
Hide Arm/Group Description:

Placebo group receiving 500 mg medicinal starch daily for 24 weeks.

Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.

placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.

GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks.

GTP group receiving 500 mg green tea polyphenols daily for 24 weeks
Placebo + Tai Chi: receiving 500 mg medicinal starch daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks
GTP + Tai Chi: receiving 500 mg green tea polyphenols daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks.
Overall Number of Participants Analyzed 37 39 37 37
Mean (Standard Deviation)
Unit of Measure: ng/mg creatinine
73.5  (50.9) 33.5  (33.1) 29.7  (21.9) 20.6  (19.8)
Time Frame 24 weeks during the study period.
Adverse Event Reporting Description Total number of participants at risk "serious and other [Non-serious] adverse events.
 
Arm/Group Title Placebo Green Tea Polyphenols (GTP) Placebo+Tai Chi (TC) GTP+TC
Hide Arm/Group Description Medicinal starch at 500 mg daily for 24 weeks Green tea polyphenols at 500 mg daily for 24 weeks Medicinal starch at 500 mg daily and Tai Chi group exercise at 1 hour/session x 3 sessions/week for 24 weeks Green tea polyphenols at 500 mg daily and Tai Chi group exercise at 1 hour/session x 3 sessions/week for 24 weeks
All-Cause Mortality
Placebo Green Tea Polyphenols (GTP) Placebo+Tai Chi (TC) GTP+TC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Green Tea Polyphenols (GTP) Placebo+Tai Chi (TC) GTP+TC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/39 (0.00%)   0/37 (0.00%)   0/37 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Green Tea Polyphenols (GTP) Placebo+Tai Chi (TC) GTP+TC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/39 (0.00%)   0/37 (0.00%)   0/37 (0.00%) 
Limitation of this study included: (1) the number of subjects in each group at the baseline was not equal. (2) The amount of dietary calcium intake for each subject was not available.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Chwan-Li Shen
Organization: Texas Tech University Health Sciences Center
Phone: (806) 743-2815
Responsible Party: Leslie Shen, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT00625391     History of Changes
Other Study ID Numbers: R21AT003735-01A1 ( U.S. NIH Grant/Contract )
R21AT003735-01A1 ( U.S. NIH Grant/Contract )
First Submitted: February 26, 2008
First Posted: February 28, 2008
Results First Submitted: December 5, 2012
Results First Posted: August 18, 2014
Last Update Posted: August 18, 2014