Clinical trial NCT02089906: Health and Nutrition Status of Chinese Elderly
Official title: Health Status of Chinese Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Sarcopenia
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2014-03-18
Enrollment: 2834
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multi-center cross-sectional study of community dwelling chinese

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

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.

Eligibility 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

Primary outcomes:
measure: Total skeletal muscle mass
timeFrame: Test Visit 1 (~ Day 7)
Secondary outcomes:
measure: Total skeletal muscle mass
timeFrame: Test Visit 2 (~ Day 17)
measure: Total body fat
timeFrame: Test Visit 1 (~Day 7) and Test Visit 2 (~ Day 17)
measure: Hand grip strength
timeFrame: Test Visit 1 (~ Day 7)
measure: Gait speed
timeFrame: Test Visit 1 (~ Day 7)
measure: Total body fat free mass
timeFrame: Test Visit 1 (~ Day 7) and Test Visit 2 (~ Day 17)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Shanghai
country: China
facility: Shanghai 6th People's Hospital
Study officials:
affiliation: Abbott Nutrition China
name: Xianfeng Zhao, MD, PhD
role: STUDY_CHAIR
References: