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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01190969
Enrollment
0
Registered
2010-08-30
Start date
2010-09-30
Completion date
2012-11-30
Last updated
2017-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Keywords

Elderly, malnutrition, nutritional supplement

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.

Interventions

DIETARY_SUPPLEMENTNutritional Supplement (Ensure Plus)

Subjects will be provided with 2 to 3 serves of Ensure Plus (complete nutritional beverages) and to be taken between meals

Sponsors

Abbott
CollaboratorINDUSTRY
Singapore General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Body weightBaseline, week 4 and week 12Body 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

MeasureTime frameDescription
Handgrip strengthBaseline, week 4 and week12Muscle grip strength will be measured at above time points
Blood AlbuminBaseline, week 4 and week12
Barthel ScoreBaseline & week12Instrumental for assessing activities daily living
Skinfold thicknessBaseline, week 4 and week 12Triceps skindfold thickness, mid arm circumference will be measured at above time points
Hospital readmissionWeek 12Above data will be collected at the end of the study
Acceptability of nutritional supplementsWeek 12Above data will be collected at the end of the study
Number of visits to general practitioner/polyclinicWeek 12Above data will be collected at the end of the study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026