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Health and Nutrition Status of Chinese Elderly

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: NCT02089906
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : August 4, 2015
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Study Description
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Brief Summary:
This study is aiming to understand the prevalence and risk factors related to malnutrition and sarcopenia in Chinese elderly.

Condition or disease
Malnutrition Sarcopenia

Detailed Description:
The study objective is to understand the prevalence of malnutrition and sarcopenia in Chinese elderly with the cut-off points from the normal range of muscle mass and function in Chinese adults; to understand the risk factors related to malnutrition and sarcopenia in Chinese elderly; to set up a screening tool on malnutrition and sarcopenia risks in Chinese elderly.
Study Design
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Study Type : Observational
Actual Enrollment : 2834 participants
Time Perspective: Prospective
Official Title: Health Status of Chinese Elderly
Study Start Date : March 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Groups and Cohorts
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Group/Cohort
Chinese Elderly
multi-center cross-sectional study


Outcome Measures
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Primary Outcome Measures :
  1. Total skeletal muscle mass [ Time Frame: Test Visit 1 (~ Day 7) ]
    bioelectric impedance absorptiometry (BIA)


Secondary Outcome Measures :
  1. Total skeletal muscle mass [ Time Frame: Test Visit 2 (~ Day 17) ]
    Dual X-ray Absorptiometry (DXA)

  2. Total body fat [ Time Frame: Test Visit 1 (~Day 7) and Test Visit 2 (~ Day 17) ]
  3. Hand grip strength [ Time Frame: Test Visit 1 (~ Day 7) ]
  4. Gait speed [ Time Frame: Test Visit 1 (~ Day 7) ]
  5. Total body fat free mass [ Time Frame: Test Visit 1 (~ Day 7) and Test Visit 2 (~ Day 17) ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Multi-center cross-sectional study of community dwelling chinese
Criteria

Inclusion Criteria:

  1. Male or female Chinese ages >= 60 years.
  2. Subject lives in the community for more than 12 months.
  3. 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 did/does heavy manual labor
  2. Subject who was a professional or semi-professional athlete or game player
  3. Subject who has physical disabilities such as loss of hand or foot or limbs or any other physical disability which may affect the muscle mass by the opinion of the study physician.
  4. Subject has an implanted electronic device or orthopedic metal implantations, such as pacemaker, cardiac defibrillator, subcutaneous injection pump, or metal hip, metal knee joint, metal fracture internal fixation, etc.
  5. Subject who has active hyperthyroidism or hypothyroidism and needs medication treatment as by self-report.
  6. Subject who has severe heart dysfunction or renal dysfunction with significant sodium water retention or edema by the opinion of study physicians.
  7. Subject who takes hormones except for external application of glucocorticoids.
  8. Subject who takes diuretics except for using a stable dose for at least 3 weeks as a part of hypertension treatment.
  9. Subject who has later stage of malignancies with cachexia by the opinion of study physicians.
  10. Subject has any other disease or situation who should not to participate in the study by the opinion of study physicians.
  11. Subject had hand/wrist or foot/leg surgery/injury within the past 3 months and the surgery/injury may affect the hand grip or gait speed test by study physician's opinion.
  12. Subject is too frail by study physician's opinion
  13. Subject is drug addicted or alcohol addicted
  14. Subject is participating in other clinical trials which are 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): NCT02089906


Locations
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China
Peking Union Medical College Hospital
Beijing, China, 100730
West China Hospital, Sichuan University
Chengdu, China, 610041
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: NCT02089906    
Other Study ID Numbers: BL22
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Sarcopenia
Malnutrition
Nutrition Disorders
Muscular Atrophy
Neuromuscular Manifestations
 Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical