Trial record 2 of 6 for:    Green Tea | NCCAM

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Leslie Shen, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00625391
First received: February 26, 2008
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Drug: Placebo
Drug: Green Tea Polyphenols (GTP)
Drug: Placebo+Tai Chi (TC)
Drug: GTP+TC
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: GTP and Tai Chi for Bone Health: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Bone formation biomarker: bone-specific alkaline phosphatase (BAP) Bone resorption biomarker: tartrate-resistant acid phosphatase (TRAP)


Secondary Outcome Measures:
  • Oxidative Stress Damage Biomarker [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Oxidative stress damage biomarker: urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG) test


Enrollment: 171
Study Start Date: February 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo pill
24 weeks of placebo.
Drug: Placebo
500 mg medicinal starch pills daily
Other Name: Placebo control group
Active Comparator: Green Tea Polyphenols (GTP)
24 weeks of green tea polyphenols
Drug: Green Tea Polyphenols (GTP)
500 mg green tea polyphenols daily
Other Name: Green tea polyphenols group
Active Comparator: Placebo+Tai Chi (TC)
24 weeks of placebo plus Tai Chi exercise.
Drug: Placebo+Tai Chi (TC)
500 mg medicinal starch daily and Tai Chi (3x/week) for 24 weeks
Other Name: Placebo plus tai chi exercise group
Active Comparator: GTP+TC
24 weeks of green tea polyphenols plus Tai Chi exercise.
Drug: GTP+TC
500 mg GTP daily plus TC exercise (3x/week) for 24 weeks
Other Name: Green tea polyphenols plus tai chi exercise group

Detailed 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625391

Locations
United States, Texas
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: Chwan-Li (Leslie) Shen, PhD Texas Tech University Health Sciences Center
  More Information

Publications:

Responsible Party: Leslie Shen, Associate Professor, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT00625391     History of Changes
Other Study ID Numbers: R21 AT003735-01A1, R21AT003735-01A1
Study First Received: February 26, 2008
Results First Received: December 5, 2012
Last Updated: August 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Texas Tech University Health Sciences Center:
postmenopausal, bone, dietary supplement, mind-body exercise

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 20, 2014