A Need-based Nutritional Intervention in Nursing Home Residents

Asia University

Status: Completed

Conditions: Malnutrition

Treatments: Other: Treatment as usual; Dietary Supplement: Nutritional supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT01741870

tsai1943

Details and patient eligibility

About

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

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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92 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

No intervention was given. All subjects received routine care

Treatment:

Other: Treatment as usual

Received nutrition supplement as needed

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Nutritional supplement

Other: Treatment as usual