MalnutritionNCT01190969
A Trial of Oral Nutritional Supplements on Nutritional Status and Clinical Outcomes
A study testing Nutritional Supplement (Ensure Plus) in people with Malnutrition, run by Singapore General Hospital.
Trial summary
The purpose of this study is to determine whether short-term use of oral nutritional supplements as part of the diet improves nutritional and functional status of post-hospitalization malnourished elderly. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- Nutritional Supplement (Ensure Plus)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Nov 2012
- Phase
- Interventional
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- over the age of 65 years old and to be discharged from Geriatric ward
- malnourished screened by Malnutrition Universal Screening Tool
Who cannot join
- are uncommunicative
- have a history of diabetes, chronic renal failure, liver disease
- are from long term residential homes like nursing homes
- incapable of taking study supplements to provide a minimum of 600 kcal/day as part of food intake
- intolerant to any of the ingredients in the study nutritional supplements
- require parenteral nutrition or enteral feeds as sole source of nutrition, e.g. patients who discharge home with tube feeding
About this study
Official title: A Randomized Controlled Trial of Oral Nutritional Supplements on Nutritional Status and Clinical Outcomes in Malnourished Elderly
The purpose of this study is to determine whether short-term use of oral nutritional supplements as part of the diet improves nutritional and functional status of post-hospitalization malnourished elderly.
Read the detailed description
Nutritional supplements have been shown to improve energy, protein, micronutrients intake, maintain or improve nutritional status in hospitalized malnourished elderly patients. However, its use in the elderly post-hospitalization is unknown, particularly in the local setting. This randomized controlled trial aims to investigate if provision of short term nutritional supplements to elderly malnourished patients after discharge from hospital improves nutritional status parameters. In addition, the impact of nutritional supplements on functional status, clinical outcome in terms of hospital readmission, number of visits to general practitioner/polyclinic and the acceptability of nutritional supplement in elderly are also examined. In this study, malnourished elderly subjects >65 years old identified by Malnutrition Universal Screening Tool from geriatric ward 63C will be recruited within 24 to 48 hours before discharge. They will be randomized into either intervention or control group. Subjects in the intervention group will receive nutritional supplements of 600 to 900 kcal as part of regular diet. As for the control group, these similar calories will be recommended from food fortification, as part of the standard care during diet counseling, to come from food. Both group subjects receive individualised assessment by the Dietitian. At baseline, nutritional status parameters such as weight, height, body mass index, skinfold thickness, handgrip strength, albumin and functional status will be measured. Subjects are then followed up at outpatient dietitian clinic 4 and 12 weeks from hospital discharge. Albumin test will be repeated at week 4 and week 12. They will keep a three-day food record end of week 1, week 4 and week 12 in order to assess their food and nutritional supplements intake. Compliance will be monitored from food diaries and interview. At the end of week 12, the same nutritional parameters will be re-evaluated for both groups. In addition, the number of hospital admissions, visits to the general practitioner/polyclinic and the acceptability of nutritional supplements will be determined. The results from this study will guide future nutritional interventions for the malnourished elderly post-hospital discharge.
- Conditions
- Malnutrition
- Being tested
- Nutritional Supplement (Ensure Plus)
- Keywords
- Elderly, malnutrition, nutritional supplement
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional Supplement (Ensure Plus)Dietary supplement
Also called Nutritional beverages
Subjects will be provided with 2 to 3 serves of Ensure Plus (complete nutritional beverages) and to be taken between meals
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight is measured to the nearest 0·01 kg using Seca clinical scales. If weight could not be measured accurately, recalled weight is used (Elia, 2003; Stratton et al. 2003a).
Measured: Baseline, week 4 and week 12
Secondary outcomes (7)
Skinfold thickness
Triceps skindfold thickness, mid arm circumference will be measured at above time points
Measured: Baseline, week 4 and week 12
Handgrip strength
Muscle grip strength will be measured at above time points
Measured: Baseline, week 4 and week12
Blood Albumin
Measured: Baseline, week 4 and week12
Barthel Score
Instrumental for assessing activities daily living
Measured: Baseline & week12
Number of visits to general practitioner/polyclinic
Above data will be collected at the end of the study
Measured: Week 12
Hospital readmission
Above data will be collected at the end of the study
Measured: Week 12
Acceptability of nutritional supplements
Above data will be collected at the end of the study
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2012 (estimated)
- Study completionNov 2012 (estimated)
Why it stopped: difficulty in recruiting elderly subjects
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.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Lee Boo Tan, BSc, MSc, Principal investigator, Dietetics & Nutrition Services, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190969
- Sponsor's protocol ID
- GNSS 2010
- Status last verified
- Feb 2017
- First submitted
- 26 Aug 2010
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Oral Nutritional Supplements on Nutritional Status and Clinical Outcomes in Malnourished Elderly
- ClinicalTrials.gov ID
- NCT01190969
- Acronym / sponsor ID
- GNSS 2010
- Conditions
- Malnutrition
- Keywords
- Elderly, malnutrition, nutritional supplement
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: difficulty in recruiting elderly subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Sep 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 30 Aug 2010 (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.
The purpose of this study is to determine whether short-term use of oral nutritional supplements as part of the diet improves nutritional and functional status of post-hospitalization malnourished elderly.
Detailed description
Nutritional supplements have been shown to improve energy, protein, micronutrients intake, maintain or improve nutritional status in hospitalized malnourished elderly patients. However, its use in the elderly post-hospitalization is unknown, particularly in the local setting. This randomized controlled trial aims to investigate if provision of short term nutritional supplements to elderly malnourished patients after discharge from hospital improves nutritional status parameters. In addition, the impact of nutritional supplements on functional status, clinical outcome in terms of hospital readmission, number of visits to general practitioner/polyclinic and the acceptability of nutritional supplement in elderly are also examined. In this study, malnourished elderly subjects >65 years old identified by Malnutrition Universal Screening Tool from geriatric ward 63C will be recruited within 24 to 48 hours before discharge. They will be randomized into either intervention or control group. Subjects in the intervention group will receive nutritional supplements of 600 to 900 kcal as part of regular diet. As for the control group, these similar calories will be recommended from food fortification, as part of the standard care during diet counseling, to come from food. Both group subjects receive individualised assessment by the Dietitian. At baseline, nutritional status parameters such as weight, height, body mass index, skinfold thickness, handgrip strength, albumin and functional status will be measured. Subjects are then followed up at outpatient dietitian clinic 4 and 12 weeks from hospital discharge. Albumin test will be repeated at week 4 and week 12. They will keep a three-day food record end of week 1, week 4 and week 12 in order to assess their food and nutritional supplements intake. Compliance will be monitored from food diaries and interview. At the end of week 12, the same nutritional parameters will be re-evaluated for both groups. In addition, the number of hospital admissions, visits to the general practitioner/polyclinic and the acceptability of nutritional supplements will be determined. The results from this study will guide future nutritional interventions for the malnourished elderly post-hospital discharge.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- over the age of 65 years old and to be discharged from Geriatric ward
- malnourished screened by Malnutrition Universal Screening Tool
Key exclusion criteria (6 listed)
- are uncommunicative
- have a history of diabetes, chronic renal failure, liver disease
- are from long term residential homes like nursing homes
- incapable of taking study supplements to provide a minimum of 600 kcal/day as part of food intake
- intolerant to any of the ingredients in the study nutritional supplements
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 |
|---|---|---|
| Nutritional Supplement (Ensure Plus)Also: Nutritional beveragesSubjects will be provided with 2 to 3 serves of Ensure Plus (complete nutritional beverages) and to be taken between meals | Dietary supplement | – |
Primary outcome
Body weight
Time frame: Baseline, week 4 and week 12
Body weight is measured to the nearest 0·01 kg using Seca clinical scales. If weight could not be measured accurately, recalled weight is used (Elia, 2003; Stratton et al. 2003a).
7 secondary outcomes
Skinfold thickness
Time frame: Baseline, week 4 and week 12
Handgrip strength
Time frame: Baseline, week 4 and week12
Blood Albumin
Time frame: Baseline, week 4 and week12
Barthel Score
Time frame: Baseline & week12
Number of visits to general practitioner/polyclinic
Time frame: Week 12
Hospital readmission
Time frame: Week 12
Acceptability of nutritional supplements
Time frame: Week 12
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 14 Feb 2017.
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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.
Lee Boo Tan, BSc, MSc principal investigator
Dietetics & Nutrition Services, Singapore General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Supplement (Ensure Plus) in people with Malnutrition, run by Singapore General Hospital.
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 2 inclusion and 6 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 14 Feb 2017. 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.
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?
Body weight (time frame: Baseline, week 4 and week 12). 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 14 Feb 2017.