Effects of a Nutritional Supplementation on the Functional Status of Frail Elders With Low Socioeconomic Status (SES)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01404299 |
Recruitment Status
:
Completed
First Posted
: July 28, 2011
Last Update Posted
: January 12, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Frail | Dietary Supplement: Nutritional Supplementation Other: Control | Not Applicable |
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 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 |

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
|
- 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)
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 65 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
Korea, Republic of | |
Gangbuk-gu Community Health Center | |
Seoul, Korea, Republic of, 142-707 |
Study Director: | Chang-O Kim, M.D, MSW | Department of District Health Care Service, Gangbuk-gu Community Health Center, Republic of Korea |
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 |