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Muscle Mass and Function in Chinese Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02089971
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Study Description
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Brief Summary:
To describe the normal range of muscle mass and function in Chinese adults.

Condition or disease
Sarcopenia

Detailed Description:
The study objective is to setup a normal range of muscle mass and function in Chinese adults.
Study Design
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Study Type : Observational
Actual Enrollment : 412 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Muscle Mass and Function in Chinese Adults
Study Start Date : March 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014
Groups and Cohorts
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Group/Cohort
Young Chinese adults
cross-sectional, observational study of community dwelling young Chinese adults


Outcome Measures
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Primary Outcome Measures :
  1. Total skeletal muscle mass [ Time Frame: Test Visit 1 (~ Day 13) ]
    Dual X-ray Absorptiometry (DXA)


Secondary Outcome Measures :
  1. Total body fat [ Time Frame: Test Visit 1 (~ Day 13) ]
  2. Total body fat free mass [ Time Frame: Test Visit 1 (~ Day 13) ]
  3. Total skeletal muscle mass [ Time Frame: Test Visit 1 (~ Day 13) ]
    Bioelectrical Impedance Absorptiometry (BIA)


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 34 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cross-sectional, observational study of young Chinese adults
Criteria

Inclusion Criteria:

  1. Young adult ages between 25 and 34 years, inclusively.
  2. Adult is judged to be in good health as determined from his/her medical history as his/her self-report to the enrolling center personnel and as confirmed through a clinical examination by a physician.
  3. Adult with BMI between 18.5 to 26.9.
  4. Male or non-pregnant non-lactating female. Non-pregnant should be confirmed by urine pregnant test. And non-lactating is defined as postpartum more than 18 months.
  5. Subject has voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.

Exclusion Criteria:

  1. Subject who is heavy manual labor.
  2. Subject who is professional or semi-professional athlete or game player.
  3. Subject who is physical disabilities, such as loss of hand or foot or limbs or any physical disability which may affect the physical activities and affect the distribution of muscle mass by the opinion of the study physician.
  4. Subject has known chronic diseases such as endocrine system diseases (including type 1 or type 2 diabetes mellitus, or hyperthyroidism or hypothyroidism), cardiovascular diseases, liver diseases, and renal diseases as self-report.
  5. Subject who has active infection of TB, HIV and hepatitis as self-report.
  6. Subject who currently experiencing diarrhea or anorexia within 7days prior to the enrollment.
  7. Subject who has or plans for intensive physical activities 3 days prior to the scheduled BIA measurement.
  8. Subject who is thyroid malfunction (as serum fT4 level and/or serum TSH level out of the reference range of the lab)
  9. Subject has implanted electronic device, orthopedic metal implantations, such as pacemaker, cardiac defibrillator, or metal hip, metal knee joint, metal fracture internal fixation, etc.
  10. Subject is drug addiction or alcohol addiction.
  11. Subject is anemia (as blood hemoglobin level less than 120 g/L in males and 110 g/L in females).
  12. Subject is malnourished by study physician's opinion
  13. Subject has active cancers as self-report
  14. Subject has lost or gained more than 5% of body weight in the past 3 months
  15. Subject attends other clinical trials and is not approved by AN
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089971


Locations
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China
Peking Union Medical College Hospital
Beijing, China, 100730
Shanghai 6th People's Hospital
Shanghai, China, 200233
Sponsors and Collaborators
Abbott Nutrition
Investigators
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Study Chair: Xianfeng Zhao, MD, PhD Abbott Nutrition China
More Information
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Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT02089971    
Other Study ID Numbers: BL23
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
 Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical