Green Tea and Tai Chi for Bone Health (GTP-TC-Bone)

Texas Tech University Health Sciences Center

Status and phase: Completed; Phase 2; Phase 1

Conditions: Osteoporosis

Treatments: Drug: Placebo; Drug: Placebo+Tai Chi (TC); Drug: GTP+TC; Drug: Green Tea Polyphenols (GTP)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00625391

R21AT003735-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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, 4, 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. Additional secondary outcome is muscle strength/physical function. Investigators evaluating the endpoints will be blinded to intervention allocation.

Enrollment: 171 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women at least 2 years after menopause (to ensure established postmenopausal status).
• Sedentary at baseline.
• Normal laboratory evaluation, thyroid function, hepatic function, renal function.
• Osteopenia.

Exclusion criteria

• History of scoliosis, severe osteoarthritis, etc., or other spinal disease that may result in anatomy unsuitable for accurate bone densitometry.
• History of cancer with some exceptions.
• History of metabolic bone disease.
• Having used anabolic steroids, calcitonin, calcitriol, alfacalcidol, etc.
• Fluoride treatment at a dose greater than 1 mg/day any time.
• History of glucocorticoid treatment.
• Any previous treatment with bisphosphonates.
• Uncontrolled intercurrent illness such as symptomatic congestive heart failure, myocardial infarction or stroke, hypertension, or terminal illness.
• Physical conditions that preclude participation of exercise intervention.
• Cognitive impairment.
• Depression.
• History of malabsorption syndrome and uncontrolled diabetes mellitus.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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171 participants in 4 patient groups, including a placebo group

Placebo pill

Placebo Comparator group

Description:

24 weeks of placebo.

Treatment:

Drug: Placebo

Green Tea Polyphenols (GTP)

Active Comparator group

Description:

24 weeks of green tea polyphenols

Treatment:

Drug: Green Tea Polyphenols (GTP)

Placebo+Tai Chi (TC)

Active Comparator group

Description:

24 weeks of placebo plus Tai Chi exercise.

Treatment:

Drug: Placebo+Tai Chi (TC)

GTP+TC

Active Comparator group

Description:

24 weeks of green tea polyphenols plus Tai Chi exercise.

Treatment:

Drug: GTP+TC