MalnutritionPhase 4NCT02360722
Improving Nutritional Status With Oral Nutritional Supplement in Chinese Elderly
A Phase 4 study testing Oral Nutritional Supplement and Nutritional Education in people with Malnutrition, run by Abbott Nutrition.
Trial summary
This is a single- country, interventional, double-arm study involving Chinese Elderly subjects. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- Oral Nutritional Supplement and Nutritional Education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Dec 2017
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female Chinese ages >= 60 years.
- Subject is ambulatory.
- Subject with risks of malnutrition defined as DETERMINE score >=3
- Subject's BMI is below 28.
- Subject has experienced hospital stay or surgery within 6 months prior to enrollment;
- Subject if takes any medications for concomitant chronic diseases should be in stable dosage for at least 3 weeks.
- Subject plans to live in the community for more than 6 months after recruitment.
- 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 has history of allergy to any ingredient in the study product
- Subject dislikes the experimental product
- Subject has been diagnosed with diabetes.
- Subject who has malignancy expected to receive chemotherapy/ radiotherapy scheduled during the study period,
- Subject has a life expectancy less than 6 months.
- Subject who has reported chronic liver disease or liver cirrhosis or liver failure or any liver diseases not suitable for the study as the study physician's opinion.
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- Subject who has reported impacted renal function as eGFR < 30 mL/min/1.73 m2 or renal dysfunction severe greater than stage 4 or any other renal diseases not suitable for the study as the study physician' s opinion.
- Subject who has experienced fever or diarrhea within one week prior to enrollment.
- Subject who is expected to have scheduled major surgery during the study period.
- 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 measurement 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 tuberculosis (TB), hepatitis, or HIV infection as self-reported at enrollment.
- Subject has severe dementia or delirium, brain metastases, eating disorder, history of significant neurological or psychiatric disorder, or other conditions that may interfere with study product consumption or compliance with study protocol procedures in the opinion of the principal investigator or study physician.
- Subject is drug addicted or alcohol addicted
- Subject has any other disease or situation who should not to participate in the study by the opinion of study physicians.
- Subject is participating in other clinical trials which are not approved by AN
About this study
This is a single- country, interventional, double-arm study involving Chinese Elderly subjects.
Read the detailed description
This study aims to understand the following:
- The effect of long-term Oral Nutritional Supplementation (ONS) on improving nutritional and health status in Chinese elderly.
- The impact of long-term ONS on health cost including both medical cost and social health care burdens.
- The impact of long-term ONS on life quality of the elderly. The study includes Screening Visit (Day -7~0), and Visit 1(Day 0) to Visit 7 (Day 168±3). Enrollment of anticipated 666 subjects, Male or female Chinese ages >= 60 years, to get 400 evaluable subjects.
- Conditions
- Malnutrition
- Being tested
- Oral Nutritional Supplement, Nutritional Education
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Nutritional SupplementOther
Will receive ONS twice a day for 6 months and two nutritional education at baseline and 3 months after intervention
Nutritional EducationOther
Two nutritional education courses at baseline and 3 months after intervention
| Study group | Role | What they receive |
|---|---|---|
| Oral Nutritional Supplement | Experimental | ONS + Nutritional education Receives: Other: Oral Nutritional Supplement; Other: Nutritional Education |
| Control Group | Other | Nutritional education only Receives: Other: Nutritional Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of body weight from baseline to the end of the study
Measured: 24 weeks
Secondary outcomes (1)
Total number of sick days due to Upper Respiratory Tract Infections (URTI)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startOct 2016
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: The study was cancelled due to change in food registration regulations in China.
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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 R&D China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360722
- Sponsor's protocol ID
- BL26
- Status last verified
- Nov 2016
- First submitted
- 27 Jan 2015
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Nutritional Status With Oral Nutritional Supplement in Chinese Elderly
- ClinicalTrials.gov ID
- NCT02360722
- Acronym / sponsor ID
- BL26
- Conditions
- Malnutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was cancelled due to change in food registration regulations in China.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 11 Feb 2015 (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 is a single- country, interventional, double-arm study involving Chinese Elderly subjects.
Detailed description
This study aims to understand the following:
- The effect of long-term Oral Nutritional Supplementation (ONS) on improving nutritional and health status in Chinese elderly.
- The impact of long-term ONS on health cost including both medical cost and social health care burdens.
- The impact of long-term ONS on life quality of the elderly. The study includes Screening Visit (Day -7~0), and Visit 1(Day 0) to Visit 7 (Day 168±3). Enrollment of anticipated 666 subjects, Male or female Chinese ages >= 60 years, to get 400 evaluable subjects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Nutritional Supplement | Experimental | Other: Oral Nutritional Supplement, Other: Nutritional EducationONS + Nutritional education |
| Control Group | Other | Other: Nutritional EducationNutritional education only |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female Chinese ages >= 60 years.
- Subject is ambulatory.
- Subject with risks of malnutrition defined as DETERMINE score >=3
- Subject's BMI is below 28.
- Subject has experienced hospital stay or surgery within 6 months prior to enrollment;
Key exclusion criteria (16 listed)
- Subject has history of allergy to any ingredient in the study product
- Subject dislikes the experimental product
- Subject has been diagnosed with diabetes.
- Subject who has malignancy expected to receive chemotherapy/ radiotherapy scheduled during the study period,
- Subject has a life expectancy less than 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Nutritional SupplementWill receive ONS twice a day for 6 months and two nutritional education at baseline and 3 months after intervention | Other | Oral Nutritional Supplement |
| Nutritional EducationTwo nutritional education courses at baseline and 3 months after intervention | Other | Control Group, Oral Nutritional Supplement |
Primary outcome
Change of body weight from baseline to the end of the study
Time frame: 24 weeks
1 secondary outcome
Total number of sick days due to Upper Respiratory Tract Infections (URTI)
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
- Individual participant dataSharing planned: No
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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 R&D China
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Nutritional Supplement and Nutritional Education in people with Malnutrition, run by Abbott Nutrition.
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 8 inclusion and 16 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: withdrawn, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change of body weight from baseline to the end of the study (time frame: 24 weeks). 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 2 Dec 2016.