Effects of a Nutritional Supplementation on the Functional Status of Frail Elders With Low Socioeconomic Status (SES)
NCT ID: NCT01404299
Last Updated: 2012-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
87 participants
INTERVENTIONAL
2011-08-31
2012-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Supplementary Group
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)
Control Group
Control
\- No intervention, except monthly home visits
Interventions
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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)
Control
\- No intervention, except monthly home visits
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
65 Years
ALL
No
Sponsors
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Gangbuk-gu Community Health Center
OTHER_GOV
Responsible Party
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Dr. Chang-O Kim
Home Visit Doctor
Principal Investigators
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Chang-O Kim, M.D, MSW
Role: STUDY_DIRECTOR
Department of District Health Care Service, Gangbuk-gu Community Health Center, Republic of Korea
Locations
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Gangbuk-gu Community Health Center
Seoul, Seoul, South Korea
Countries
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Other Identifiers
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GCHC_FRAIL
Identifier Type: -
Identifier Source: org_study_id
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