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Completed

NCT Number: NCT02089906

Health and Nutrition Status of Chinese Elderly

This study is aiming to understand the prevalence and risk factors related to malnutrition and sarcopenia in Chinese elderly.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female Chinese ages >= 60 years.
  • Subject lives in the community for more than 12 months.
  • 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

  • Subject who did/does heavy manual labor
  • Subject who was a professional or semi-professional athlete or game player
  • 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.
  • 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.
  • Subject who has active hyperthyroidism or hypothyroidism and needs medication treatment as by self-report.
  • Subject who has severe heart dysfunction or renal dysfunction with significant sodium water retention or edema by the opinion of study physicians.
  • Subject who takes hormones except for external application of glucocorticoids.
  • Subject who takes diuretics except for using a stable dose for at least 3 weeks as a part of hypertension treatment.
  • Subject who has later stage of malignancies with cachexia by the opinion of study physicians.
  • Subject has any other disease or situation who should not to participate in the study by the opinion of study physicians.
  • 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.
  • Subject is too frail by study physician's opinion
  • Subject is drug addicted or alcohol addicted
  • Subject is participating in other clinical trials which are not approved by AN

Treatment and study plan

Primary outcomes

  1. Total skeletal muscle mass

    Time frame: Test Visit 1 (~ Day 7)

    bioelectric impedance absorptiometry (BIA)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Health Status of Chinese Elderly

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2014
Registry last updated
Aug 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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