Health and Nutrition Status of Chinese Elderly

Sarcopenia Clinical Trial

Official title:

Health Status of Chinese Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089906
• Other study ID #: BL22
• Status: Completed
• Phase: N/A
• First received: March 14, 2014
• Last updated: August 3, 2015
• Start date: March 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2834
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Malnutrition
• Sarcopenia

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	West China Hospital, Sichuan University	Chengdu
China	Shanghai 6th People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total skeletal muscle mass	bioelectric impedance absorptiometry (BIA)	Test Visit 1 (~ Day 7)	No
Secondary	Total skeletal muscle mass	Dual X-ray Absorptiometry (DXA)	Test Visit 2 (~ Day 17)	No
Secondary	Total body fat		Test Visit 1 (~Day 7) and Test Visit 2 (~ Day 17)	No
Secondary	Hand grip strength		Test Visit 1 (~ Day 7)	No
Secondary	Gait speed		Test Visit 1 (~ Day 7)	No
Secondary	Total body fat free mass		Test Visit 1 (~ Day 7) and Test Visit 2 (~ Day 17)	No