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OsteoporosisPhase 1/2GTP-TC-BoneNCT00625391

Green Tea and Tai Chi for Bone Health

A Phase 1/2 study testing Green Tea Polyphenols (GTP) and GTP+TC in people with Osteoporosis, run by Texas Tech University Health Sciences Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Osteoporosis
What is being tested?
Green Tea Polyphenols (GTP) and GTP+TC
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
171 participants
Where
1 siteUnited States
Study dates
Feb 2008to Aug 2009
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430

Other trials in United States

About this study

Official title: GTP and Tai Chi for Bone Health: a Pilot Study

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.

Read the 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.

Conditions
Osteoporosis
Being tested
Placebo, Green Tea Polyphenols (GTP), Placebo+Tai Chi (TC), GTP+TC
Keywords
postmenopausal, bone, dietary supplement, mind-body exercise
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Also called Placebo control group

    500 mg medicinal starch pills daily

  • Green Tea Polyphenols (GTP)Drug

    Also called Green tea polyphenols group

    500 mg green tea polyphenols daily

  • Placebo+Tai Chi (TC)Drug

    Also called Placebo plus tai chi exercise group

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

  • GTP+TCDrug

    Also called Green tea polyphenols plus tai chi exercise group

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

Study groups in NCT00625391
Study groupRoleWhat they receive
Placebo pillPlacebo comparator24 weeks of placebo.
Receives: Drug: Placebo
Green Tea Polyphenols (GTP)Active comparator24 weeks of green tea polyphenols
Receives: Drug: Green Tea Polyphenols (GTP)
Placebo+Tai Chi (TC)Active comparator24 weeks of placebo plus Tai Chi exercise.
Receives: Drug: Placebo+Tai Chi (TC)
GTP+TCActive comparator24 weeks of green tea polyphenols plus Tai Chi exercise.
Receives: Drug: GTP+TC

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 24 weeks

Secondary outcomes (1)

  1. Oxidative Stress Damage Biomarker

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

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionAug 2009
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00625391
Sponsor's protocol ID
R21AT003735-01A1
Other IDs
R21AT003735-01A1
Acronym
GTP-TC-Bone
Status last verified
Aug 2014
First submitted
26 Feb 2008
Last updated
18 Aug 2014
Data monitoring committee
No

Publications

  • Shen CL, Chyu MC, Yeh JK, Felton CK, Xu KT, Pence BC, Wang JS. Green tea polyphenols and Tai Chi for bone health: designing a placebo-controlled randomized trial. BMC Musculoskelet Disord. 2009 Sep 4;10:110. doi: 10.1186/1471-2474-10-110.

    PubMed 19732445

  • Shen CL, Yeh JK, Cao JJ, Chyu MC, Wang JS. Green tea and bone health: Evidence from laboratory studies. Pharmacol Res. 2011 Aug;64(2):155-61. doi: 10.1016/j.phrs.2011.03.012. Epub 2011 Apr 5.

    PubMed 21473914

  • Shen CL, Yeh JK, Cao JJ, Wang JS. Green tea and bone metabolism. Nutr Res. 2009 Jul;29(7):437-56. doi: 10.1016/j.nutres.2009.06.008.

    PubMed 19700031

  • Shen CL, Chyu MC, Wang JS. Tea and bone health: steps forward in translational nutrition. Am J Clin Nutr. 2013 Dec;98(6 Suppl):1694S-1699S. doi: 10.3945/ajcn.113.058255. Epub 2013 Oct 30.

    PubMed 24172296

  • Shen CL, Chyu MC, Yeh JK, Zhang Y, Pence BC, Felton CK, Brismee JM, Arjmandi BH, Doctolero S, Wang JS. Effect of green tea and Tai Chi on bone health in postmenopausal osteopenic women: a 6-month randomized placebo-controlled trial. Osteoporos Int. 2012 May;23(5):1541-52. doi: 10.1007/s00198-011-1731-x. Epub 2011 Jul 16.

    PubMed 21766228

  • Shen CL, Chyu MC, Pence BC, Yeh JK, Zhang Y, Felton CK, Doctolero S, Wang JS. Green tea polyphenols supplementation and Tai Chi exercise for postmenopausal osteopenic women: safety and quality of life report. BMC Complement Altern Med. 2010 Dec 9;10:76. doi: 10.1186/1472-6882-10-76.

    PubMed 21143878

  • Qian G, Xue K, Tang L, Wang F, Song X, Chyu MC, Pence BC, Shen CL, Wang JS. Mitigation of oxidative damage by green tea polyphenols and Tai Chi exercise in postmenopausal women with osteopenia. PLoS One. 2012;7(10):e48090. doi: 10.1371/journal.pone.0048090. Epub 2012 Oct 31.

    PubMed 23118932

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Green Tea Polyphenols (GTP) and GTP+TC in people with Osteoporosis, run by Texas Tech University Health Sciences Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00625391, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2014.

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