A Need-based Nutritional Intervention in Nursing Home Residents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-12-31

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.

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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.

Conditions

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Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control

No intervention was given. All subjects received routine care

Group Type PLACEBO_COMPARATOR

Treatment as usual

Intervention Type OTHER

routine care

Received nutrition supplement as needed

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.

Group Type ACTIVE_COMPARATOR

Nutritional supplement

Intervention Type DIETARY_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

Treatment as usual

Intervention Type OTHER

routine care

Interventions

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Nutritional 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

Intervention Type DIETARY_SUPPLEMENT

Treatment as usual

routine care

Intervention Type OTHER

Eligibility Criteria

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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