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

Frail Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404299
• Other study ID #: GCHC_FRAIL
• Status: Completed
• Phase: N/A
• First received: July 27, 2011
• Last updated: January 10, 2012
• Start date: August 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Gangbuk-gu Community Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and WelfareUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Frail

Intervention

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:
• Control
- No intervention, except monthly home visits

Locations

Country	Name	City	State
Korea, Republic of	Gangbuk-gu Community Health Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangbuk-gu Community Health Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Status	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)	12 weeks	Yes
Secondary	Nutritional Status, Other Functionality Test	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)	12 weeks	Yes