A Need-based Nutritional Intervention in Nursing Home Residents

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: Nutritional supplement; Other: Treatment as usual

• Registration Number: NCT01741870
• Lead Sponsor: Asia University

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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-10
• Study Completion: 2011-12
• Study First Submitted: 2012-11-29
• Study First Submitted QC: 2012-12-03
• Study First Posted: 2012-12-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Received nutrition supplement as needed	Treatment as usual	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.
Control	Treatment as usual	No intervention was given. All subjects received routine care
Received nutrition supplement as needed	Nutritional supplement	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Biochemical indicators	Baseline, 12, and 24 weeks	Change from baseline in serum albumin and cholesterol concentrations, and hemoglobin, hematocrit and lymphocyte count status at 12, and 24 weeks.

Trial Locations

Locations (1)

Asia University; 🇨🇳 Taichung, Taiwan