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

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ClinicalTrials.gov Identifier: NCT01404299
Recruitment Status : Completed
First Posted : July 28, 2011
Last Update Posted : January 12, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. Chang-O Kim, Gangbuk-gu Community Health Center

Study Description
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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
Frail Dietary Supplement: Nutritional Supplementation Other: Control Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : August 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : January 2012

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Arms and Interventions
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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 Name: Greenbia HP (Dr. Jung's Food Co., Ltd., Korea)
No Intervention: Control Group Other: Control
- No intervention, except monthly home visits


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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)


Eligibility Criteria
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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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: July 28, 2011    Key Record Dates
Last Update Posted: January 12, 2012
Last Verified: January 2012

Keywords provided by Dr. Chang-O Kim, Gangbuk-gu Community Health Center:
Frailty,
nutritional supplementation,
functional status