UndernutritionPhase 3NCT02656186
Supplementation With Nutrients Modulating IGF-1 and Cytokines in Elderly People at Risk of Undernutrition
A Phase 3 study testing Pre-intervention and Liquid nutritional supplement in people with Undernutrition, run by Yonsei University.
Trial summary
The purpose of this study was to determine the improvement in nutritional status, especially in the level of insulin-like growth factor-1 (IGF-1) and its relationship with changes in the circulating cytokine levels, after providing extra protein and energy contents to community-dwelling older adults at risk of… Read more about this study
- Who is it for?
- Ages 65 to 86 years
- Conditions the study is for
- Undernutrition
- What is being tested?
- Pre-intervention and Liquid nutritional supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Dec 2015
- Phase
- Phase 3
- 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 to 86 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- voluntarily agree to participate and sign in informed consent form
- aged 65 years or older
- a serum prealbumin level≤30 mg/dL and a BMI<25 kg/m2
Who cannot join
- inability to perform oral ingestion
- known allergies to milk or eggs
- an inability to communicate, such as those with Alzheimer's disease
- malabsorption syndrome, a history of gastrectomy or enterectomy
- diabetes, liver disease, renal disease, neurological disease, pancreatitis, malignancy, cardiovascular or cerebrovascular disease, metabolic syndrome
- any other disease requiring treatment, medication or alcohol abuse
- any condition that the investigator believes may put the subjects at under risk
About this study
Official title: Supplementation With Nutrients Modulating IGF-1 Negatively Correlated With Changes in the Levels of Proinflammatory Cytokines in Community-dwelling Elderly People at Risk of Undernutrition
The purpose of this study was to determine the improvement in nutritional status, especially in the level of insulin-like growth factor-1 (IGF-1) and its relationship with changes in the circulating cytokine levels, after providing extra protein and energy contents to community-dwelling older adults at risk of undernutrition.
Read the detailed description
Sixty of aged over 65 years, living independently in the community for elderly people, nondiabetic subjects with serum prealbumin of under 30 mg/dL and BMI under 25 kg/m2 were recruited. The subjects were followed for a 2-week pre-intervention period, followed by an intervention period, which they received 2 cartons of liquid oral nutritional supplementation daily for 2 weeks.
- Conditions
- Undernutrition
- Being tested
- Pre-intervention, Liquid nutritional supplement
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-interventionDietary supplement
First 2-weeks : keeping routine dietary habit
Liquid nutritional supplementDietary supplement
Pre-intervention period was followed by an intervention period, during which consumed twice-daily 200 mL cartons of oral liquid nutritional supplementation (total 400 mL daily, containing 16 g protein, 12 g fat and 60 g carbohydrate and providing 400 kcal)
| Study group | Role | What they receive |
|---|---|---|
| Single-arm pretest-posttest | Experimental | In this study, the subjects served as their own controls. Subjects who were eligible based on inclusion criteria first entered into a 2-week pre-intervention period, during which they received nutrition counseling to keep their routine dietary habits. This was followed by an intervention period, during which an oral nutritional supplement was used over a period of 2 weeks. Receives: Dietary Supplement: Pre-intervention; Dietary Supplement: Liquid nutritional supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prealbumin (mg/dL)
Measured: at pre-treatment (week -2)
Prealbumin (mg/dL)
Measured: at baseline (week 0)
Prealbumin (mg/dL)
Measured: at post-treatment (week 2)
Transferrin (mg/dL)
Measured: at pre-treatment (week -2)
Transferrin (mg/dL)
Measured: at baseline (week 0)
Transferrin (mg/dL)
Measured: at post-treatment (week 2)
Secondary outcomes (5)
Weight (kg)
3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
Measured: 4 weeks
Body mass index (kg/m2)
3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
Measured: 4 weeks
Serum albumin (g/dL)
3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
Measured: 4 weeks
Insulin growth factor-1 (ng/mL)
3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
Measured: 4 weeks
Osmolality (mOsm/kgH2O)
3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UndernutritionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong Ho Lee, Ph.D., Study director, Department of Food & Nutrition, College of Human Ecology, Yonsei University 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656186
- Sponsor's protocol ID
- YO_elderly
- Status last verified
- Jan 2016
- First submitted
- 12 Jan 2016
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim M, Kim M, Lee YJ, Song HJ, Shim JK, Chang DH, Yu WK, Lee SH, Lee JH. Supplementation with nutrients modulating insulin-like growth factor-1 negatively correlated with changes in the levels of pro-inflammatory cytokines in community-dwelling elderly people at risk of undernutrition. J Hum Nutr Diet. 2017 Feb;30(1):27-35. doi: 10.1111/jhn.12447. Epub 2016 Dec 9.
PubMed 27933679
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation With Nutrients Modulating IGF-1 Negatively Correlated With Changes in the Levels of Proinflammatory Cytokines in Community-dwelling Elderly People at Risk of Undernutrition
- ClinicalTrials.gov ID
- NCT02656186
- Acronym / sponsor ID
- YO_elderly
- Conditions
- Undernutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Jan 2016 (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 was to determine the improvement in nutritional status, especially in the level of insulin-like growth factor-1 (IGF-1) and its relationship with changes in the circulating cytokine levels, after providing extra protein and energy contents to community-dwelling older adults at risk of undernutrition.
Detailed description
Sixty of aged over 65 years, living independently in the community for elderly people, nondiabetic subjects with serum prealbumin of under 30 mg/dL and BMI under 25 kg/m2 were recruited. The subjects were followed for a 2-week pre-intervention period, followed by an intervention period, which they received 2 cartons of liquid oral nutritional supplementation daily for 2 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm pretest-posttest | Experimental | Dietary Supplement: Pre-intervention, Dietary Supplement: Liquid nutritional supplementIn this study, the subjects served as their own controls. Subjects who were eligible based on inclusion criteria first entered into a 2-week pre-intervention period, during which they received nutrition counseling to keep their routine dietary habits. This was followed by an intervention period, during which an oral nutritional supplement was used over a period of 2 weeks. |
Who may qualify
- Ages
- 65 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- voluntarily agree to participate and sign in informed consent form
- aged 65 years or older
- a serum prealbumin level≤30 mg/dL and a BMI<25 kg/m2
Key exclusion criteria (7 listed)
- inability to perform oral ingestion
- known allergies to milk or eggs
- an inability to communicate, such as those with Alzheimer's disease
- malabsorption syndrome, a history of gastrectomy or enterectomy
- diabetes, liver disease, renal disease, neurological disease, pancreatitis, malignancy, cardiovascular or cerebrovascular disease, metabolic syndrome
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 |
|---|---|---|
| Pre-interventionFirst 2-weeks : keeping routine dietary habit | Dietary supplement | Single-arm pretest-posttest |
| Liquid nutritional supplementPre-intervention period was followed by an intervention period, during which consumed twice-daily 200 mL cartons of oral liquid nutritional supplementation (total 400 mL daily, containing 16 g protein, 12 g fat and 60 g carbohydrate and providing 400 kcal) | Dietary supplement | Single-arm pretest-posttest |
Primary outcome
Prealbumin (mg/dL)
Time frame: at pre-treatment (week -2)
Prealbumin (mg/dL)
Time frame: at baseline (week 0)
Prealbumin (mg/dL)
Time frame: at post-treatment (week 2)
Transferrin (mg/dL)
Time frame: at pre-treatment (week -2)
Transferrin (mg/dL)
Time frame: at baseline (week 0)
Transferrin (mg/dL)
Time frame: at post-treatment (week 2)
5 secondary outcomes
Weight (kg)
Time frame: 4 weeks
Body mass index (kg/m2)
Time frame: 4 weeks
Serum albumin (g/dL)
Time frame: 4 weeks
Insulin growth factor-1 (ng/mL)
Time frame: 4 weeks
Osmolality (mOsm/kgH2O)
Time frame: 4 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 18 Jan 2016.
- Derived from this study: PubMed 27933679Kim M, Kim M, Lee YJ, Song HJ, Shim JK, Chang DH, Yu WK, Lee SH, Lee JH. Supplementation with nutrients modulating insulin-like growth factor-1 negatively correlated with changes in the levels of pro-inflammatory cytokines in community-dwelling elderly people at risk of undernutrition. J Hum Nutr Diet. 2017 Feb;30(1):27-35. doi: 10.1111/jhn.12447. Epub 2016 Dec 9.
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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.
Jong Ho Lee, Ph.D. study director
Department of Food & Nutrition, College of Human Ecology, Yonsei University 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pre-intervention and Liquid nutritional supplement in people with Undernutrition, run by Yonsei University.
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 7 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 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Prealbumin (mg/dL) (time frame: at pre-treatment (week -2)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02656186, which also lists 1 linked publication.
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 18 Jan 2016.