Critical IllnessNCT02569203
Effect of Immune-enhancing Enteral Nutrition on Immunomodulation in Critically Ill Patients
A study testing standard enteral nutrition, high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan and high-protein enteral nutrition of immune modulating nutrients without β-glucan in people with Critical Illness, run by Yonsei University.
Trial summary
To determine whether high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan stimulates immune functions compared with standard enteral nutrition (control: 20% of total calorie from protein) or high-protein (24% of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness
- What is being tested?
- standard enteral nutrition, high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan and high-protein enteral nutrition of immune modulating nutrients without β-glucan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Sep 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ICU patients
Who cannot join
- ICU patients who could not receiving enteral nutrition
About this study
Official title: Effects of Enteral Formula Including Immune-modulating Nutrients on Clinical Course and Immune Function in Critically Ill Patients
To determine whether high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan stimulates immune functions compared with standard enteral nutrition (control: 20% of total calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients without β-glucan in critically ill patients.
Read the detailed description
To determine whether high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan stimulates immune functions compared with standard enteral nutrition (control: 20% of total calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients without β-glucan in critically ill patients. In a randomized double-blind placebo-controlled study, 30 patients consumed 1 of 3 enteral nutrition: control, enteral nutrition of immune modulating nutrients enriched with β-glucan (250mg/L) or enteral nutrition of immune modulating nutrients without β-glucan. Enteral nutrition was initiated within 24 hours of ICU admission and continued during the ICU stay for a 7 days.
- Conditions
- Critical Illness
- Being tested
- standard enteral nutrition, high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan, high-protein enteral nutrition of immune modulating nutrients without β-glucan
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard enteral nutritionDietary supplement
Also called control group
standard enteral nutrition
high-protein enteral nutrition of immune modulating nutrients enriched with β-glucanDietary supplement
Also called test group I
high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan
high-protein enteral nutrition of immune modulating nutrients without β-glucanDietary supplement
Also called test group II
high-protein enteral nutrition of immune modulating nutrients without β-glucan
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | standard enteral nutrition Receives: Dietary Supplement: standard enteral nutrition |
| test group I | Experimental | high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan Receives: Dietary Supplement: high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan |
| test group II | Experimental | high-protein enteral nutrition of immune modulating nutrients without β-glucan Receives: Dietary Supplement: high-protein enteral nutrition of immune modulating nutrients without β-glucan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline NK cell activity at 7 days
NK cell activity (%)
Measured: at baseline and 7 days follow-up
Secondary outcomes (2)
Change from baseline IL-12 at 7 days
IL-12 (pg/mL)
Measured: at baseline and 7 days follow-up
Change from baseline hs-CRP at 7 days
hs-CRP (mg/dL)
Measured: at baseline and 7 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startApr 2014
- Primary completionSep 2015
- Study completionSep 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 Critical IllnessStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong Ho Lee, Ph. D., Principal investigator, Dept. of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-749, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569203
- Sponsor's protocol ID
- BT_ICU_immune
- Status last verified
- Oct 2015
- First submitted
- 24 Sep 2015
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee JG, Kim YS, Lee YJ, Ahn HY, Kim M, Kim M, Cho MJ, Cho Y, Lee JH. Effect of Immune-Enhancing Enteral Nutrition Enriched with or without Beta-Glucan on Immunomodulation in Critically Ill Patients. Nutrients. 2016 Jun 2;8(6):336. doi: 10.3390/nu8060336.
PubMed 27271657
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Enteral Formula Including Immune-modulating Nutrients on Clinical Course and Immune Function in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02569203
- Acronym / sponsor ID
- BT_ICU_immune
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Oct 2015 (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.
To determine whether high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan stimulates immune functions compared with standard enteral nutrition (control: 20% of total calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients without β-glucan in critically ill patients.
Detailed description
To determine whether high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan stimulates immune functions compared with standard enteral nutrition (control: 20% of total calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients without β-glucan in critically ill patients. In a randomized double-blind placebo-controlled study, 30 patients consumed 1 of 3 enteral nutrition: control, enteral nutrition of immune modulating nutrients enriched with β-glucan (250mg/L) or enteral nutrition of immune modulating nutrients without β-glucan. Enteral nutrition was initiated within 24 hours of ICU admission and continued during the ICU stay for a 7 days.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Dietary Supplement: standard enteral nutritionstandard enteral nutrition |
| test group I | Experimental | Dietary Supplement: high-protein enteral nutrition of immune modulating nutrients enriched with β-glucanhigh-protein enteral nutrition of immune modulating nutrients enriched with β-glucan |
| test group II | Experimental | Dietary Supplement: high-protein enteral nutrition of immune modulating nutrients without β-glucanhigh-protein enteral nutrition of immune modulating nutrients without β-glucan |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ICU patients
Key exclusion criteria (1 listed)
- ICU patients who could not receiving enteral nutrition
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 |
|---|---|---|
| standard enteral nutritionAlso: control groupstandard enteral nutrition | Dietary supplement | control group |
| high-protein enteral nutrition of immune modulating nutrients enriched with β-glucanAlso: test group Ihigh-protein enteral nutrition of immune modulating nutrients enriched with β-glucan | Dietary supplement | test group I |
| high-protein enteral nutrition of immune modulating nutrients without β-glucanAlso: test group IIhigh-protein enteral nutrition of immune modulating nutrients without β-glucan | Dietary supplement | test group II |
Primary outcome
Change from baseline NK cell activity at 7 days
Time frame: at baseline and 7 days follow-up
NK cell activity (%)
2 secondary outcomes
Change from baseline IL-12 at 7 days
Time frame: at baseline and 7 days follow-up
Change from baseline hs-CRP at 7 days
Time frame: at baseline and 7 days follow-up
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 6 Oct 2015.
- Derived from this study: PubMed 27271657Lee JG, Kim YS, Lee YJ, Ahn HY, Kim M, Kim M, Cho MJ, Cho Y, Lee JH. Effect of Immune-Enhancing Enteral Nutrition Enriched with or without Beta-Glucan on Immunomodulation in Critically Ill Patients. Nutrients. 2016 Jun 2;8(6):336. doi: 10.3390/nu8060336.
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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. principal investigator
Dept. of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-749, South Korea
Questions about this trial
What is this clinical trial studying?
A study testing standard enteral nutrition, high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan and high-protein enteral nutrition of immune modulating nutrients without β-glucan in people with Critical Illness, 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 1 inclusion and 1 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 6 Oct 2015. 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. Some participants in this study may receive a placebo. 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?
Change from baseline NK cell activity at 7 days (time frame: at baseline and 7 days follow-up). 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 NCT02569203, 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 6 Oct 2015.