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Completed

NCT Number: NCT01404299

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gangbuk-gu Community Health Center

Seoul, 142-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nutritional supplementation

Dietary Supplement
  • 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 names: Greenbia HP (Dr. Jung's Food Co., Ltd., Korea)

Control

Other
  • No intervention, except monthly home visits

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Gangbuk-gu Community Health Center

Other Gov

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jul 28, 2011
Registry last updated
Jan 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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