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

This study has been withdrawn prior to enrollment.
(difficulty in recruiting elderly subjects)
Sponsor:
Collaborator:
Abbott
Information provided by:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01190969
First received: August 26, 2010
Last updated: June 15, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Malnutrition
Dietary Supplement: Nutritional Supplement (Ensure Plus)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial of Oral Nutritional Supplements on Nutritional Status and Clinical Outcomes in Malnourished Elderly

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Body weight [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]
    Triceps skindfold thickness, mid arm circumference will be measured at above time points

  • Handgrip strength [ Time Frame: Baseline, week 4 and week12 ] [ Designated as safety issue: No ]
    Muscle grip strength will be measured at above time points

  • Blood Albumin [ Time Frame: Baseline, week 4 and week12 ] [ Designated as safety issue: No ]
  • Barthel Score [ Time Frame: Baseline & week12 ] [ Designated as safety issue: No ]
    Instrumental for assessing activities daily living

  • Number of visits to general practitioner/polyclinic [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Above data will be collected at the end of the study

  • Hospital readmission [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Above data will be collected at the end of the study

  • Acceptability of nutritional supplements [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Above data will be collected at the end of the study


Estimated Enrollment: 120
Study Start Date: September 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Nutritional Supplement (Ensure Plus)
    Subjects will be provided with 2 to 3 serves of Ensure Plus (complete nutritional beverages) and to be taken between meals
    Other Name: Nutritional beverages
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.

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190969

Sponsors and Collaborators
Singapore General Hospital
Abbott
Investigators
Principal Investigator: Lee Boo Tan, BSc, MSc Dietetics & Nutrition Services, Singapore General Hospital
  More Information

No publications provided

Responsible Party: Lee Boo Tan, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01190969     History of Changes
Other Study ID Numbers: GNSS 2010
Study First Received: August 26, 2010
Last Updated: June 15, 2011
Health Authority: Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)

Keywords provided by Singapore General Hospital:
Elderly
malnutrition
nutritional supplement

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 29, 2014