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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Withdrawn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
Singapore General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Malnutrition focused on measuring Elderly, malnutrition, nutritional supplement

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 26, 2010
    Last Updated
    February 12, 2017
    Sponsor
    Singapore General Hospital
    Collaborators
    Abbott
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    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

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    A Trial of Oral Nutritional Supplements on Nutritional Status and Clinical Outcomes

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