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A Need-based Nutritional Intervention in Nursing Home Residents

The Effectiveness of a Need-based Nutritional Intervention Strategy to Improve the Nutritional Status of Elderly Nursing Home Residents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01741870
Enrollment
92
Registered
2012-12-05
Start date
2011-04-30
Completion date
2011-12-31
Last updated
2024-07-31

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

Conditions

Malnutrition

Keywords

Nutritional supplement, Nutritional status, Physical functional activity, Nursing home elderly

Brief summary

To examine the effectiveness of a need-based nutritional intervention strategy in improving the nutritional and physical functional status of nursing home elderly.

Detailed description

Ninety-two nursing home residents aged 65 years or older and BMI \<25 were randomly assigned to the intervention or control groups. Subjects in the treatment group received a soy-protein-based nutritional supplement, if his/her BMI was \<24kg/m2 and nutritional score was \<24 according to the Mini Nutritional Assessment. The supplementation would be suspended if both conditions were not met. At baseline and every 4 weeks up to 24 weeks, thereafter, all subjects were measured for anthropometric parameters. At baseline, 12 weeks and 24 weeks subjects were measured for blood biochemical indicators, handgrip strength and Barthel's index.

Interventions

DIETARY_SUPPLEMENTNutritional supplement

Subjects will receive 50 g/day of a soy protein-based nutritional supplement containing 9.5 g protein, 250 kcal energy and all essential micronutrients

OTHERTreatment as usual

routine care

Sponsors

Asia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

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

Inclusion criteria

1. ≥ 65 years of age 2. BMI ≤ 25 (kg/m2) 3. ≥1 month of residency 4. Able to self-feed or receive oral-feeding 5. Non-bed-ridden 6. Cognitively able to answer the questionnaire

Exclusion criteria

1.Hospitalized or having acute infection/diseases

Design outcomes

Primary

MeasureTime frameDescription
Assessment of nutritional status with the Mini nutritional Assessment (MNA)Baseline and every 4 weeks, up to 24 weeksChange from baseline in MNA score at 4, 8, 12, 16, 20 and 24 weeks

Secondary

MeasureTime frameDescription
Biochemical indicatorsBaseline, 12, and 24 weeksChange from baseline in serum albumin and cholesterol concentrations, and hemoglobin, hematocrit and lymphocyte count status at 12, and 24 weeks.

Other

MeasureTime frameDescription
Physical functional statusBaseline, 12 and 24 weeksChange from baseline in Barthel's index and handgrip strength at 12 and 24 weeks
Hospital admissionsBaseline, and 24 weeksFrequency of outpatient visits, emergency visits and hospital admission (length of stay) during the study

Countries

Taiwan

Outcome results

None listed

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