A Trial of Oral Nutritional Supplements on Nutritional Status and Clinical Outcomes
Primary Purpose
Malnutrition
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutritional Supplement (Ensure Plus)
Sponsored by
About this trial
This is an interventional health services research trial for Malnutrition focused on measuring Elderly, malnutrition, nutritional supplement
Eligibility Criteria
Inclusion Criteria:
- over the age of 65 years old and to be discharged from Geriatric ward
- malnourished screened by Malnutrition Universal Screening Tool
Exclusion Criteria:
- 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
Sites / Locations
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Skinfold thickness
Triceps skindfold thickness, mid arm circumference will be measured at above time points
Handgrip strength
Muscle grip strength will be measured at above time points
Blood Albumin
Barthel Score
Instrumental for assessing activities daily living
Number of visits to general practitioner/polyclinic
Above data will be collected at the end of the study
Hospital readmission
Above data will be collected at the end of the study
Acceptability of nutritional supplements
Above data will be collected at the end of the study
Full Information
NCT ID
NCT01190969
First Posted
August 26, 2010
Last Updated
February 12, 2017
Sponsor
Singapore General Hospital
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT01190969
Brief Title
A Trial of Oral Nutritional Supplements on Nutritional Status and Clinical Outcomes
Official Title
A Randomized Controlled Trial of Oral Nutritional Supplements on Nutritional Status and Clinical Outcomes in Malnourished Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
difficulty in recruiting elderly subjects
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Elderly, malnutrition, nutritional supplement
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional Supplement (Ensure Plus)
Other Intervention Name(s)
Nutritional beverages
Intervention Description
Subjects will be provided with 2 to 3 serves of Ensure Plus (complete nutritional beverages) and to be taken between meals
Primary Outcome Measure Information:
Title
Body weight
Description
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).
Time Frame
Baseline, week 4 and week 12
Secondary Outcome Measure Information:
Title
Skinfold thickness
Description
Triceps skindfold thickness, mid arm circumference will be measured at above time points
Time Frame
Baseline, week 4 and week 12
Title
Handgrip strength
Description
Muscle grip strength will be measured at above time points
Time Frame
Baseline, week 4 and week12
Title
Blood Albumin
Time Frame
Baseline, week 4 and week12
Title
Barthel Score
Description
Instrumental for assessing activities daily living
Time Frame
Baseline & week12
Title
Number of visits to general practitioner/polyclinic
Description
Above data will be collected at the end of the study
Time Frame
Week 12
Title
Hospital readmission
Description
Above data will be collected at the end of the study
Time Frame
Week 12
Title
Acceptability of nutritional supplements
Description
Above data will be collected at the end of the study
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
over the age of 65 years old and to be discharged from Geriatric ward
malnourished screened by Malnutrition Universal Screening Tool
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Boo Tan, BSc, MSc
Organizational Affiliation
Dietetics & Nutrition Services, Singapore General Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Trial of Oral Nutritional Supplements on Nutritional Status and Clinical Outcomes
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