Trial Outcomes & Findings for Green Tea and Tai Chi for Bone Health (NCT NCT00625391)
NCT ID: NCT00625391
Last Updated: 2014-08-18
Results Overview
Bone formation biomarker: bone-specific alkaline phosphatase (BAP) Bone resorption biomarker: tartrate-resistant acid phosphatase (TRAP)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
171 participants
Primary outcome timeframe
24 weeks
Results posted on
2014-08-18
Participant Flow
Recruitment period: March 2008 - December 2008. Location: community setting
There was no any significant events arranged.
Participant milestones
| Measure |
Placebo Group
Placebo group receiving 500 mg medicinal starch daily for 24 weeks.
|
Green Tea Polyphenols (GTP) Group
Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.
|
Placebo + Tai Chi Group
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
GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
44
|
47
|
42
|
38
|
|
Overall Study
COMPLETED
|
37
|
39
|
37
|
37
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
5
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Green Tea and Tai Chi for Bone Health
Baseline characteristics by cohort
| Measure |
Placebo
n=44 Participants
Placebo group receiving 500 mg medicinal starch daily for 24 weeks.
|
Green Tea Polyphenols (GTP)
n=47 Participants
Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.
|
Placebo+Tai Chi
n=42 Participants
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
n=38 Participants
GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
149 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 6.7 • n=4 Participants
|
57.4 years
STANDARD_DEVIATION 6.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
171 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
47 participants
n=7 Participants
|
42 participants
n=5 Participants
|
38 participants
n=4 Participants
|
171 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Analyzed on those who completed the study. Percent change relative to the baseline for each group.
Bone formation biomarker: bone-specific alkaline phosphatase (BAP) Bone resorption biomarker: tartrate-resistant acid phosphatase (TRAP)
Outcome measures
| Measure |
Placebo
n=37 Participants
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.
|
Green Tea Polyphenols
n=39 Participants
GTP group receiving 500 mg green tea polyphenols daily for 24 weeks
|
Placebo + Tai Chi
n=37 Participants
Placebo + Tai Chi: receiving 500 mg medicinal starch daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks
|
Green Tea Polyphenol + Tai Chi
n=37 Participants
GTP + Tai Chi: receiving 500 mg green tea polyphenols daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks.
|
|---|---|---|---|---|
|
Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker
|
106.1 percentage change from baseline
Standard Deviation 3.7
|
103.6 percentage change from baseline
Standard Deviation 2.9
|
112.3 percentage change from baseline
Standard Deviation 3.0
|
113.0 percentage change from baseline
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Analyzed who completed the study.
Oxidative stress damage biomarker: urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG) test
Outcome measures
| Measure |
Placebo
n=37 Participants
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.
|
Green Tea Polyphenols
n=39 Participants
GTP group receiving 500 mg green tea polyphenols daily for 24 weeks
|
Placebo + Tai Chi
n=37 Participants
Placebo + Tai Chi: receiving 500 mg medicinal starch daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks
|
Green Tea Polyphenol + Tai Chi
n=37 Participants
GTP + Tai Chi: receiving 500 mg green tea polyphenols daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks.
|
|---|---|---|---|---|
|
Oxidative Stress Damage Biomarker
|
73.5 ng/mg creatinine
Standard Deviation 50.9
|
33.5 ng/mg creatinine
Standard Deviation 33.1
|
29.7 ng/mg creatinine
Standard Deviation 21.9
|
20.6 ng/mg creatinine
Standard Deviation 19.8
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Green Tea Polyphenols (GTP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo+Tai Chi (TC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GTP+TC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Chwan-Li Shen
Texas Tech University Health Sciences Center
Phone: (806) 743-2815
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place