A Need-based Nutritional Intervention in Nursing Home Residents

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: Nutritional supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 65 years of age BMI ≤ 25 (kg/m2) ≥1 month of residency Able to self-feed or receive oral-feeding Non-bed-ridden Cognitively able to answer the questionnaire Exclusion Criteria: 1.Hospitalized or having acute infection/diseases

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>No intervention was given. All subjects received routine care | |
| Active Comparator: Received nutrition supplement as needed<br>Subjects in this group received 50 g/day soy protein-based nutritional supplement (containing 9.5 g protein, 250 kcal energy and all essential micro-nutrients) whenever subjects BMI is below 24 and MNA score also below 24. | Dietary Supplement: Nutritional supplement<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of nutritional status with the Mini nutritional Assessment (MNA) | Change from baseline in MNA score at 4, 8, 12, 16, 20 and 24 weeks | Baseline and every 4 weeks, up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical indicators | Change from baseline in serum albumin and cholesterol concentrations, and hemoglobin, hematocrit and lymphocyte count status at 12, and 24 weeks. | Baseline, 12, and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional supplement, Nutritional status, Physical functional activity, Nursing home elderly