NCT02089906

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,834

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 4, 2015

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

March 14, 2014

Last Update Submit

August 3, 2015

Conditions

MalnutritionSarcopenia

Outcome Measures

Primary Outcomes (1)

  • Total skeletal muscle mass

    bioelectric impedance absorptiometry (BIA)

    Test Visit 1 (~ Day 7)

Secondary Outcomes (5)

  • Total skeletal muscle mass

    Test Visit 2 (~ Day 17)

  • Total body fat

    Test Visit 1 (~Day 7) and Test Visit 2 (~ Day 17)

  • Hand grip strength

    Test Visit 1 (~ Day 7)

  • Gait speed

    Test Visit 1 (~ Day 7)

  • Total body fat free mass

    Test Visit 1 (~ Day 7) and Test Visit 2 (~ Day 17)

Study Arms (1)

Chinese Elderly

multi-center cross-sectional study

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Multi-center cross-sectional study of community dwelling chinese

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

West China Hospital, Sichuan University

Chengdu, 610041, China

Location

Shanghai 6th People's Hospital

Shanghai, 200233, China

Location

MeSH Terms

Conditions

MalnutritionSarcopenia

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Xianfeng Zhao, MD, PhD

    Abbott Nutrition China

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 18, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 4, 2015

Record last verified: 2015-08

Locations

CN(3)