Health and Nutrition Status of Chinese Elderly | NCT02089906

Studies
Health and Nutrition Status of Chinese Elderly

NCT02089906

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

Aug 4, 2015Estimated

Enrollment

2,834Actual

Phase

Not provided

Conditions

Malnutrition
Sarcopenia

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Mar 14, 2014

First Submission Date that Met QC Criteria

Mar 17, 2014

First Posted Date

Mar 18, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2015

Last Update Posted Date

Aug 4, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,834Actual

Label	Type	Description	Intervention Names
Chinese Elderly		multi-center cross-sectional study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total skeletal muscle mass	bioelectric impedance absorptiometry (BIA)	Test Visit 1 (~ Day 7)

Secondary Outcomes

Measure	Description	Time Frame
Total skeletal muscle mass	Dual X-ray Absorptiometry (DXA)	Test Visit 2 (~ Day 17)
Total body fat		Test Visit 1 (~Day 7) and Test Visit 2 (~ Day 17)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Multi-center cross-sectional study of community dwelling chinese

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital		Beijing		100730	China
West China Hospital, Sichuan University

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D009133	Muscular Atrophy
D020879	Neuromuscular Manifestations

ID	Term
D044342	Malnutrition
D055948	Sarcopenia