FrailNCT01404299
Effects of a Nutritional Supplementation on the Functional Status of Frail Elders With Low Socioeconomic Status (SES)
A study testing Nutritional Supplementation in people with Frail, run by Gangbuk-gu Community Health Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail
- What is being tested?
- Nutritional Supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gangbuk-gu Community Health Center
Seoul, Seoul, 142-707
About this study
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
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.
Read the 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.
- Conditions
- Frail
- Being tested
- Nutritional Supplementation, Control
- Keywords
- Frailty,, nutritional supplementation,, functional status
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional SupplementationDietary supplement
Also called Greenbia HP (Dr. Jung's Food Co., Ltd., Korea)
- 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)
ControlOther
- No intervention, except monthly home visits
| Study group | Role | What they receive |
|---|---|---|
| Supplementary Group | Experimental | Not described Receives: Dietary Supplement: Nutritional Supplementation |
| Control Group | No intervention | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (1)
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangbuk-gu Community Health Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Chang-O Kim, Gangbuk-gu Community Health Center
- Investigators
- Chang-O Kim, M.D, MSW, Study director, Department of District Health Care Service, Gangbuk-gu Community Health Center, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404299
- Sponsor's protocol ID
- GCHC_FRAIL
- Status last verified
- Jan 2012
- First submitted
- 27 Jul 2011
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01404299
- Acronym / sponsor ID
- GCHC_FRAIL
- Conditions
- Frail
- Keywords
- Frailty,, nutritional supplementation,, functional status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Gangbuk-gu Community Health CenterOther government
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 28 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplementary Group | Experimental | Dietary Supplement: Nutritional Supplementation |
| Control Group | No intervention | Other: Control |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional SupplementationAlso: Greenbia HP (Dr. Jung's Food Co., Ltd., Korea)- 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) | Dietary supplement | Supplementary Group |
| Control- No intervention, except monthly home visits | Other | Control Group |
Primary outcome
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)
1 secondary outcome
Nutritional Status, Other Functionality Test
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang-O Kim, M.D, MSW study director
Department of District Health Care Service, Gangbuk-gu Community Health Center, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Supplementation in people with Frail, run by Gangbuk-gu Community Health Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Status (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2012.