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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
History of Changes
  Purpose
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 Intervention
Frail
 Dietary Supplement: Nutritional Supplementation
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gangbuk-gu Community Health Center:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)
Enrollment: 87
Study Start Date: August 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Greenbia HP (Dr. Jung's Food Co., Ltd., Korea)
No Intervention: Control Group Other: Control
- No intervention, except monthly home visits

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.

  Eligibility
Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404299

Locations
Korea, Republic of
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
  More Information

Responsible Party: Dr. Chang-O Kim, Home Visit Doctor, Gangbuk-gu Community Health Center
ClinicalTrials.gov Identifier: NCT01404299     History of Changes
Other Study ID Numbers: GCHC_FRAIL 
Study First Received: July 27, 2011
Last Updated: January 10, 2012
Health Authority: Korea: Ministry for Health and Welfare
United States: Federal Government

Keywords provided by Gangbuk-gu Community Health Center:
Frailty,
nutritional supplementation,
functional status

ClinicalTrials.gov processed this record on September 30, 2016