Health and Nutrition Status of Chinese Elderly

NCT ID: NCT02089906

Last Updated: 2015-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2834 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-07-31

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.

Conditions

Malnutrition; Sarcopenia

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Chinese Elderly

multi-center cross-sectional study

No interventions assigned to this group

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott Nutrition

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xianfeng Zhao, MD, PhD

Role: STUDY_CHAIR

Abbott Nutrition China

Locations

Peking Union Medical College Hospital

Beijing, , China

West China Hospital, Sichuan University

Chengdu, , China

Shanghai 6th People's Hospital

Shanghai, , China

Countries

China

Other Identifiers

BL22

Identifier Type: -

Identifier Source: org_study_id