Green Tea and Tai Chi for Bone Health

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tai Chi for Osteopenic Women

NCT01039012

Osteopenia

UNKNOWN PHASE2

Tocotrienols and Bone Health of Postmenopausal Women

NCT02058420

Osteoporosis

COMPLETED PHASE1/PHASE2

Effects of High-Intensity Interval Training on Bone Health in Hong Kong Older Women

NCT06888544

Osteopenia

RECRUITING NA

Tart Cherry Supplementation and Women's Bone Health Study

NCT04167150

Osteoporosis, Postmenopausal Osteoporosis, Age-Related

COMPLETED NA

Parameters of Exercise to Prevent Osteoporosis

NCT04063813

Osteoporosis, Postmenopausal

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo pill

24 weeks of placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

500 mg medicinal starch pills daily

Green Tea Polyphenols (GTP)

24 weeks of green tea polyphenols

Group Type ACTIVE_COMPARATOR

Green Tea Polyphenols (GTP)

Intervention Type DRUG

500 mg green tea polyphenols daily

Placebo+Tai Chi (TC)

24 weeks of placebo plus Tai Chi exercise.

Group Type ACTIVE_COMPARATOR

Placebo+Tai Chi (TC)

Intervention Type DRUG

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

GTP+TC

24 weeks of green tea polyphenols plus Tai Chi exercise.

Group Type ACTIVE_COMPARATOR

GTP+TC

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

500 mg medicinal starch pills daily

Intervention Type DRUG

Green Tea Polyphenols (GTP)

500 mg green tea polyphenols daily

Intervention Type DRUG

Placebo+Tai Chi (TC)

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

Intervention Type DRUG

GTP+TC

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Placebo control group Green tea polyphenols group Placebo plus tai chi exercise group Green tea polyphenols plus tai chi exercise group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes