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Completed

NCT Number: NCT00625391

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 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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

500 mg medicinal starch pills daily

Other names: Placebo control group

Green Tea Polyphenols (GTP)

Drug

500 mg green tea polyphenols daily

Other names: Green tea polyphenols group

Placebo+Tai Chi (TC)

Drug

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

Other names: Placebo plus tai chi exercise group

GTP+TC

Drug

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

Other names: Green tea polyphenols plus tai chi exercise group

Primary outcomes

  1. Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker

    Time frame: 24 weeks

    Bone formation biomarker: bone-specific alkaline phosphatase (BAP) Bone resorption biomarker: tartrate-resistant acid phosphatase (TRAP)

Secondary outcomes

  1. Oxidative Stress Damage Biomarker

    Time frame: 24 weeks

    Oxidative stress damage biomarker: urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG) test

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

GTP and Tai Chi for Bone Health: a Pilot Study

Acronym: GTP-TC-Bone

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 28, 2008
Registry last updated
Aug 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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