Effects of a Nutritional Supplementation on the Functional Status of Frail Elders With Low Socioeconomic Status (SES)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether protein-energy nutritional supplementation improves geriatric function in community-dwelling frail older adults of low socioeconomic status.

Detailed Description
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Chronic undernutrition is a common condition in older people, and is clearly an important component of frailty. However, the effect of protein-energy nutritional supplementation on the functional status of frail older people is controversial. Some investigators suggested that, if nutritional or functional status has deteriorated too far, it could be very difficult for single nutritional supplementation to reverse malnutrition progression or functional decline. The investigators believe one of the reasons for these ineffective results, especially for the community-dwelling frail elderly, may be due to a lack of regard to the socioeconomic status of the study population. For this reason, the investigators recruited a study sample with low socioeconomic status and evaluated the effect of protein-energy nutritional supplementation on their disability scores and physical performance.

Official Title
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Effects of a Protein-Energy Nutritional Supplementation on the Functional Status of Frail Older Adults With Low Socioeconomic Status: A Community-based Randomized Trial

Conditions
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Frail

Intervention / Treatment
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* Dietary Supplement: Nutritional Supplementation
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older adults over 65 years of age, registered in the National Home Healthcare Service database Require more than 5 seconds to perform 3m walking test (Usual Gait Speed <0.6 m/sec) Get less than 24 points on Mini Nutritional Assessment (Mini Nutritional Assessment <24) Exclusion Criteria: Unable to walk or are too functionally deteriorated to receive home health care services Who were participating in any kind of exercise program or clinical nutrition program who were restricted to a high-protein diet by an internist (i.e., for liver failure or severe renal failure)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplementary Group<br> | Dietary Supplement: Nutritional Supplementation<br>* - Providing two 200mL per day of commercial liquid formula cans for 12 weeks (additional 400kal of energy, 25g of protein, 9.4g of essential amino acids (60.2% leucine), 400mL of water, and micronutrients per day)<br>* Other names: Greenbia HP (Dr. Jung's Food Co., Ltd., Korea);|
| No Intervention: Control Group<br> | Other: Control<br>* - No intervention, except monthly home visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Status | Physical Functioning (Self-reported disability score which was specially developed to measure geriatric function in the community-dwelling frail elderly of Korea), Short Physical Performance Battery (Objective measurement of functional performance developed at the Established Population for Epidemiologic Studies of the Elderly) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional Status, Other Functionality Test | Dietary Intake Data, Body Weight, Mid-arm Circumference, Hand Grip Strength, Timed-up-and-go Test, Usual gait speed, One Leg Stands, BUN (Serum), Creatinine (Serum) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty,, nutritional supplementation,, functional status