NCT02089971

Brief Summary

To describe the normal range of muscle mass and function in Chinese adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
412

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Shorter than P25 for all trials

Geographic Reach
1 country

2 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
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

7 months

First QC Date

March 14, 2014

Last Update Submit

January 16, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total skeletal muscle mass

    Dual X-ray Absorptiometry (DXA)

    Test Visit 1 (~ Day 13)

Secondary Outcomes (3)

  • Total body fat

    Test Visit 1 (~ Day 13)

  • Total body fat free mass

    Test Visit 1 (~ Day 13)

  • Total skeletal muscle mass

    Test Visit 1 (~ Day 13)

Study Arms (1)

Young Chinese adults

cross-sectional, observational study of community dwelling young Chinese adults

Eligibility Criteria

Age25 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Cross-sectional, observational study of young Chinese adults

You may qualify if:

  • Young adult ages between 25 and 34 years, inclusively.
  • Adult is judged to be in good health as determined from his/her medical history as his/her self-report to the enrolling center personnel and as confirmed through a clinical examination by a physician.
  • Adult with BMI between 18.5 to 26.9.
  • Male or non-pregnant non-lactating female. Non-pregnant should be confirmed by urine pregnant test. And non-lactating is defined as postpartum more than 18 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 is heavy manual labor.
  • Subject who is professional or semi-professional athlete or game player.
  • Subject who is physical disabilities, such as loss of hand or foot or limbs or any physical disability which may affect the physical activities and affect the distribution of muscle mass by the opinion of the study physician.
  • Subject has known chronic diseases such as endocrine system diseases (including type 1 or type 2 diabetes mellitus, or hyperthyroidism or hypothyroidism), cardiovascular diseases, liver diseases, and renal diseases as self-report.
  • Subject who has active infection of TB, HIV and hepatitis as self-report.
  • Subject who currently experiencing diarrhea or anorexia within 7days prior to the enrollment.
  • Subject who has or plans for intensive physical activities 3 days prior to the scheduled BIA measurement.
  • Subject who is thyroid malfunction (as serum fT4 level and/or serum TSH level out of the reference range of the lab)
  • Subject has implanted electronic device, orthopedic metal implantations, such as pacemaker, cardiac defibrillator, or metal hip, metal knee joint, metal fracture internal fixation, etc.
  • Subject is drug addiction or alcohol addiction.
  • Subject is anemia (as blood hemoglobin level less than 120 g/L in males and 110 g/L in females).
  • Subject is malnourished by study physician's opinion
  • Subject has active cancers as self-report
  • Subject has lost or gained more than 5% of body weight in the past 3 months
  • Subject attends other clinical trials and is not approved by AN

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Shanghai 6th People's Hospital

Shanghai, 200233, China

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular 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
Observational Model
ECOLOGIC OR COMMUNITY
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

October 1, 2014

Study Completion

December 1, 2014

Last Updated

January 19, 2015

Record last verified: 2015-01

Locations