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Green Tea and Tai Chi for Bone Health

NCT00625391 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2014-08-18

Study results available
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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.

Conditions

Interventions

DRUG

Placebo

500 mg medicinal starch pills daily

DRUG

Green Tea Polyphenols (GTP)

500 mg green tea polyphenols daily

DRUG

Placebo+Tai Chi (TC)

500 mg medicinal starch daily and Tai Chi (3x/week) for 24 weeks

DRUG

GTP+TC

500 mg GTP daily plus TC exercise (3x/week) for 24 weeks

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Texas Tech University Health Sciences Center

    lead OTHER

Principal Investigators

  • Chwan-Li (Leslie) Shen, PhD · Texas Tech University Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
FACTORIAL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00625391 on ClinicalTrials.gov