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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:
Gangbuk-gu Community Health Center
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
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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 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:
Further study details as provided by Dr. Chang-O Kim, Gangbuk-gu Community Health Center:
Primary Outcome 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 Outcome 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)
| 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) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01404299
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 |
Keywords provided by Dr. Chang-O Kim, Gangbuk-gu Community Health Center:
|
Frailty, nutritional supplementation, functional status |
ClinicalTrials.gov processed this record on June 23, 2017