Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Need-based Nutritional Intervention in Nursing Home Residents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741870
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : December 5, 2012
Sponsor:
Information provided by (Responsible Party):
Alan C. Tsai, Ph. D., 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.

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: Nutritional supplement Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of a Need-based Nutritional Intervention Strategy to Improve the Nutritional Status of Elderly Nursing Home Residents
Study Start Date : April 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
No intervention was given. All subjects received routine care
Active Comparator: 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.
Dietary Supplement: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741870


Locations
Layout table for location information
Taiwan
Asia University
Taichung, Taiwan, 41354
Sponsors and Collaborators
Asia University
Investigators
Layout table for investigator information
Principal Investigator: Alan C Tsai, PhD Professor, Dept. of Healthcare Adm., Asia University, 500 liufeng Road, Wufeng, Taichung, Taiwan 41354
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Alan C. Tsai, Ph. D., professor, Asia University
ClinicalTrials.gov Identifier: NCT01741870    
Other Study ID Numbers: tsai1943
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: December 2012
Keywords provided by Alan C. Tsai, Ph. D., Asia University:
Nutritional supplement
Nutritional status
Physical functional activity
Nursing home elderly
Additional relevant MeSH terms:
Layout table for MeSH terms
Malnutrition
Nutrition Disorders