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

Not Applicable

Completed

• Conditions: Frail
• Interventions: Dietary Supplement: Nutritional Supplementation; Other: Control

• Registration Number: NCT01404299
• Lead Sponsor: Gangbuk-gu Community Health Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-07-27
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-28
• Study Start: 2011-08
• Primary Completion: 2011-12
• Status Verified: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-01-10
• Last Update Posted: 2012-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supplementary Group	Nutritional Supplementation	-
Control Group	Control	-

Primary Outcome Measures

Name	Time	Method
Functional Status	12 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Nutritional Status, Other Functionality Test	12 weeks	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)

Trial Locations

Locations (1)

Gangbuk-gu Community Health Center; 🇰🇷 Seoul, Korea, Republic of