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

Malnutrition Clinical Trial

Official title:

A Randomized Controlled Trial of Oral Nutritional Supplements on Nutritional Status and Clinical Outcomes in Malnourished Elderly

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01190969
• Other study ID #: GNSS 2010
• Status: Withdrawn
• Phase: N/A
• First received: August 26, 2010
• Last updated: February 12, 2017
• Start date: September 2010
• Est. completion date: November 2012

Study information

• Verified date: February 2017
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Singapore General Hospital	Abbott

Outcome

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