SarcopeniaNCT02089971
Muscle Mass and Function in Chinese Adults
An observational study of Sarcopenia, run by Abbott Nutrition at 2 sites in China.
Trial summary
To describe the normal range of muscle mass and function in Chinese adults. Read more about this study
- Who is it for?
- Ages 25 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- How many people
- 412 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 34 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Cross-sectional, observational study of young Chinese adults
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking Union Medical College Hospital
Beijing, 100730
Shanghai 6th People's Hospital
Shanghai, 200233
About this study
To describe the normal range of muscle mass and function in Chinese adults.
Read the detailed description
The study objective is to setup a normal range of muscle mass and function in Chinese adults.
- Conditions
- Sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Young Chinese adults | cross-sectional, observational study of community dwelling young Chinese adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total skeletal muscle mass
Dual X-ray Absorptiometry (DXA)
Measured: Test Visit 1 (~ Day 13)
Secondary outcomes (3)
Total body fat
Measured: Test Visit 1 (~ Day 13)
Total body fat free mass
Measured: Test Visit 1 (~ Day 13)
Total skeletal muscle mass
Bioelectrical Impedance Absorptiometry (BIA)
Measured: Test Visit 1 (~ Day 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xianfeng Zhao, MD, PhD, Study chair, Abbott Nutrition China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089971
- Sponsor's protocol ID
- BL23
- Status last verified
- Jan 2015
- First submitted
- 14 Mar 2014
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Mass and Function in Chinese Adults
- ClinicalTrials.gov ID
- NCT02089971
- Acronym / sponsor ID
- BL23
- Conditions
- Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To describe the normal range of muscle mass and function in Chinese adults.
Detailed description
The study objective is to setup a normal range of muscle mass and function in Chinese adults.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young Chinese adults | – | –cross-sectional, observational study of community dwelling young Chinese adults |
Who may qualify
- Ages
- 25 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Cross-sectional, observational study of young Chinese adults
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total skeletal muscle mass
Time frame: Test Visit 1 (~ Day 13)
Dual X-ray Absorptiometry (DXA)
3 secondary outcomes
Total body fat
Time frame: Test Visit 1 (~ Day 13)
Total body fat free mass
Time frame: Test Visit 1 (~ Day 13)
Total skeletal muscle mass
Time frame: Test Visit 1 (~ Day 13)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xianfeng Zhao, MD, PhD study chair
Abbott Nutrition China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by Abbott Nutrition at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total skeletal muscle mass (time frame: Test Visit 1 (~ Day 13)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2015.