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

NCT01404299 | Completed DMC

• 1 other identifier: GCHC_FRAIL
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Frail

Keywords

Frailty,; nutritional supplementation,; functional status

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Nutritional Status, Other Functionality Test

  12 weeks

Study Arms (2)

Supplementary Group

EXPERIMENTAL

Dietary Supplement: Nutritional Supplementation

Control Group

NO INTERVENTION

Other: Control

Interventions

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)

Also known as: Greenbia HP (Dr. Jung's Food Co., Ltd., Korea)

Supplementary Group

Control OTHER

\- No intervention, except monthly home visits

Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gangbuk-gu Community Health Center: lead

Study Sites (1)

Gangbuk-gu Community Health Center

Seoul, Seoul, 142-707, South Korea

Location

MeSH Terms

Conditions

Frailty

Interventions

Dietary Supplements; Long-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Chang-O Kim, M.D, MSW

  Department of District Health Care Service, Gangbuk-gu Community Health Center, Republic of Korea

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Home Visit Doctor

Study Record Dates

• First Submitted: July 27, 2011
• First Posted: July 28, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: January 12, 2012

Record last verified: 2012-01

Locations

KR (1)