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

Sponsor
Gangbuk-gu Community Health Center (Other)
Overall Status
Completed
CT.gov ID
NCT01404299
Collaborator
(none)
87
Enrollment
1
Location
2
Arms
5
Duration (Months)
17.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Nutritional Supplementation
  • Other: Control
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
87 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
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 Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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)

    		•
    No Intervention: Control Group

    Other: Control
    - No intervention, except monthly home visits

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gangbuk-gu Community Health Center Seoul Korea, Republic of 142-707

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Chang-O Kim, Home Visit Doctor, Gangbuk-gu Community Health Center
    ClinicalTrials.gov Identifier:
    NCT01404299
    Other Study ID Numbers:
    • GCHC_FRAIL
    First Posted:
    Jul 28, 2011
    Last Update Posted:
    Jan 12, 2012
    Last Verified:
    Jan 1, 2012
    Keywords provided by Dr. Chang-O Kim, Home Visit Doctor, Gangbuk-gu Community Health Center
    Frailty,
    nutritional supplementation,
    functional status

    Study Results

    No Results Posted as of Jan 12, 2012