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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Chang-O Kim, Gangbuk-gu Community Health Center
ClinicalTrials.gov Identifier:
NCT01404299
First received: July 27, 2011
Last updated: January 10, 2012
Last verified: January 2012

July 27, 2011
January 10, 2012
August 2011
December 2011   (final data collection date for primary outcome measure)
Functional Status [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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)
Functional Status and Serologic Inflammatory Marker [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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), Interleukin-6 (serum), Tumor Necrosis Factor-alpha (serum)
Complete list of historical versions of study NCT01404299 on ClinicalTrials.gov Archive Site
Nutritional Status, Other Functionality Test [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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)
Nutritional Status, Other Functionality Test [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Dietary Intake Data, Mini-nutritional Assessment, Simplified Nutritional Assessment Questionnaire, Body Weight, Mid-arm Circumference, Calf Circumference, Hand Grip Strength, Timed-up-and-go Test, One Leg Stands, Albumin (Serum), Total Lymphocyte Count (Whole blood)
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Frail
  • 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 Name: Greenbia HP (Dr. Jung's Food Co., Ltd., Korea)
  • Other: Control
    - No intervention, except monthly home visits
  • Experimental: Supplementary Group
    Intervention: Dietary Supplement: Nutritional Supplementation
  • No Intervention: Control Group
    Intervention: Other: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
January 2012
December 2011   (final data collection date for primary outcome measure)

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)
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01404299
GCHC_FRAIL
Yes
Dr. Chang-O Kim, Gangbuk-gu Community Health Center
Gangbuk-gu Community Health Center
Not Provided
Study Director: Chang-O Kim, M.D, MSW Department of District Health Care Service, Gangbuk-gu Community Health Center, Republic of Korea
Gangbuk-gu Community Health Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP