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

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.

Study Overview

• Status: Withdrawn
• Conditions: Malnutrition
• Intervention / Treatment: Dietary supplement: Nutritional Supplement (Ensure Plus)

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, week 4 and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skinfold thickness	Triceps skindfold thickness, mid arm circumference will be measured at above time points	Baseline, week 4 and week 12
Handgrip strength	Muscle grip strength will be measured at above time points	Baseline, week 4 and week12
Blood Albumin		Baseline, week 4 and week12
Barthel Score	Instrumental for assessing activities daily living	Baseline & week12
Number of visits to general practitioner/polyclinic	Above data will be collected at the end of the study	Week 12
Hospital readmission	Above data will be collected at the end of the study	Week 12
Acceptability of nutritional supplements	Above data will be collected at the end of the study	Week 12

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Collaborators: Abbott
• Investigators: Principal Investigator: Lee Boo Tan, BSc, MSc, Dietetics & Nutrition Services, Singapore General Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): November 1, 2012

Study Registration Dates

• First Submitted: August 26, 2010
• First Submitted That Met QC Criteria: August 27, 2010
• First Posted (Estimate): August 30, 2010

Study Record Updates

• Last Update Posted (Actual): February 14, 2017
• Last Update Submitted That Met QC Criteria: February 12, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Elderly; malnutrition; nutritional supplement
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: GNSS 2010