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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2011

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.

Interventions

  • 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: Control
    • – No intervention, except monthly home visits

Arms, Groups and Cohorts

  • Experimental: Supplementary Group
  • No Intervention: Control Group

Clinical Trial Outcome Measures

Primary Measures

  • Functional Status
    • Time Frame: 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 Measures

  • Nutritional Status, Other Functionality Test
    • Time Frame: 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)

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gangbuk-gu Community Health Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Chang-O Kim, Home Visit Doctor – Gangbuk-gu Community Health Center
  • Overall Official(s)
    • Chang-O Kim, M.D, MSW, Study Director, Department of District Health Care Service, Gangbuk-gu Community Health Center, Republic of Korea

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.