NCT01190969

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

August 26, 2010

Last Update Submit

February 12, 2017

Conditions

Malnutrition

Keywords

Elderlymalnutritionnutritional supplement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Skinfold thickness

    Baseline, week 4 and week 12

  • Handgrip strength

    Baseline, week 4 and week12

  • Blood Albumin

    Baseline, week 4 and week12

  • Barthel Score

    Baseline & week12

  • Number of visits to general practitioner/polyclinic

    Week 12

  • +2 more secondary outcomes

Interventions

Nutritional Supplement (Ensure Plus)DIETARY_SUPPLEMENT

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

Also known as: Nutritional beverages

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • over the age of 65 years old and to be discharged from Geriatric ward
  • malnourished screened by Malnutrition Universal Screening Tool

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Malnutrition

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Lee Boo Tan, BSc, MSc

    Dietetics & Nutrition Services, Singapore General Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2010

First Posted

August 30, 2010

Study Start

September 1, 2010

Primary Completion

June 1, 2012

Study Completion

November 1, 2012

Last Updated

February 14, 2017

Record last verified: 2017-02