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Completed

NCT Number: NCT01741870

A Need-based Nutritional Intervention in Nursing Home Residents

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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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asia University

Taichung, 41354, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional Supplement

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

Other

routine care

Primary outcomes

  1. Assessment of nutritional status with the Mini nutritional Assessment (MNA)

    Time frame: 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 outcomes

  1. Biochemical indicators

    Time frame: 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.

Other outcomes

  1. Physical functional status

    Time frame: Baseline, 12 and 24 weeks

    Change from baseline in Barthel's index and handgrip strength at 12 and 24 weeks

  2. Hospital admissions

    Time frame: Baseline, and 24 weeks

    Frequency of outpatient visits, emergency visits and hospital admission (length of stay) during the study

Sponsors and collaborators

Lead sponsor

Asia University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 5, 2012
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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