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

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

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.

Study Overview

• Status: Completed
• Conditions: Frail
• Intervention / Treatment: Dietary supplement: Nutritional Supplementation; Other: Control

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 Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 142-707
    • Gangbuk-gu Community Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group	Other: Control; - No intervention, except monthly home visits
Experimental: Supplementary Group	Dietary supplement: Nutritional Supplementation; - 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); Other Names: Greenbia HP (Dr. Jung's Food Co., Ltd., Korea)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gangbuk-gu Community Health Center
• Investigators: Study Director: Chang-O Kim, M.D, MSW, Department of District Health Care Service, Gangbuk-gu Community Health Center, Republic of Korea

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: July 27, 2011
• First Submitted That Met QC Criteria: July 27, 2011
• First Posted (Estimate): July 28, 2011

Study Record Updates

• Last Update Posted (Estimate): January 12, 2012
• Last Update Submitted That Met QC Criteria: January 10, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: functional status; Frailty,; nutritional supplementation,
• Other Study ID Numbers: GCHC_FRAIL