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

Effects of a Protein-Energy Nutritional Supplementation on the Functional Status of Frail Older Adults With Low Socioeconomic Status: A Community-based Randomized Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01404299

Enrollment

Registered

2011-07-28

Start date

2011-08-31

Completion date

2012-01-31

Last updated

2012-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frail

Keywords

Frailty,, nutritional supplementation,, functional status

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.

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.

Interventions

DIETARY_SUPPLEMENTNutritional 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)

OTHERControl

\- No intervention, except monthly home visits

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Functional Status	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

Measure	Time frame	Description
Nutritional Status, Other Functionality Test	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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026