MalnutritionNCT02089906
Health and Nutrition Status of Chinese Elderly
An observational study of Malnutrition and Sarcopenia, run by Abbott Nutrition at 3 sites in China.
Trial summary
This study is aiming to understand the prevalence and risk factors related to malnutrition and sarcopenia in Chinese elderly. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Sarcopenia
- How many people
- 2,834 participants
- Where
- 3 sitesChina
- Study dates
- Mar 2014to Jul 2015
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Multi-center cross-sectional study of community dwelling chinese
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
Peking Union Medical College Hospital
Beijing, 100730
West China Hospital, Sichuan University
Chengdu, 610041
Shanghai 6th People's Hospital
Shanghai, 200233
About this study
Official title: Health Status of Chinese Elderly
This study is aiming to understand the prevalence and risk factors related to malnutrition and sarcopenia in Chinese elderly.
Read the 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.
- Conditions
- Malnutrition, Sarcopenia
- Medical subject headings
- Malnutrition, 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 |
|---|---|---|
| Chinese Elderly | multi-center cross-sectional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total skeletal muscle mass
bioelectric impedance absorptiometry (BIA)
Measured: Test Visit 1 (~ Day 7)
Secondary outcomes (5)
Total skeletal muscle mass
Dual X-ray Absorptiometry (DXA)
Measured: Test Visit 2 (~ Day 17)
Total body fat
Measured: Test Visit 1 (~Day 7) and Test Visit 2 (~ Day 17)
Hand grip strength
Measured: Test Visit 1 (~ Day 7)
Gait speed
Measured: Test Visit 1 (~ Day 7)
Total body fat free mass
Measured: Test Visit 1 (~ Day 7) and Test Visit 2 (~ Day 17)
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 completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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
- Time perspective
- Prospective
- Enrolment
- 2,834 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
- NCT02089906
- Sponsor's protocol ID
- BL22
- Status last verified
- Aug 2015
- First submitted
- 14 Mar 2014
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Status of Chinese Elderly
- ClinicalTrials.gov ID
- NCT02089906
- Acronym / sponsor ID
- BL22
- Conditions
- Malnutrition, Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,834 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (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.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese Elderly | – | –multi-center cross-sectional study |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Multi-center cross-sectional study of community dwelling chinese
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
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 7)
bioelectric impedance absorptiometry (BIA)
5 secondary outcomes
Total skeletal muscle mass
Time frame: Test Visit 2 (~ Day 17)
Total body fat
Time frame: Test Visit 1 (~Day 7) and Test Visit 2 (~ Day 17)
Hand grip strength
Time frame: Test Visit 1 (~ Day 7)
Gait speed
Time frame: Test Visit 1 (~ Day 7)
Total body fat free mass
Time frame: Test Visit 1 (~ Day 7) and Test Visit 2 (~ Day 17)
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 4 Aug 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Sarcopenia, run by Abbott Nutrition at 3 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 3 inclusion and 14 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 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 7)). 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 4 Aug 2015.