Acute Respiratory FailurePhase 2/3NCT02421614
Enteral Feeding Composition and Acute Respiratory Failure
A Phase 2/3 study testing high-protein low-carbohydrate diet with high olive oil and high-protein low-carbohydrate diet with high sunflower oil in people with Acute Respiratory Failure, run by Zahra Vahdat Shariatpanahi at 1 site in Iran.
Trial summary
This study aimed to investigate the effect of enteral feeding's macronutrient composition on inflammatory mediators, oxidative stress and outcomes in Intensive Care Unit (ICU) patients with acute respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- high-protein low-carbohydrate diet with high olive oil and high-protein low-carbohydrate diet with high sunflower oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIran
- Study dates
- Aug 2013to Dec 2015
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- enrolled in ICU
- age older than 18 years old
- need to be mechanically ventilation
- have enteral feeding
- no previous diabetes
- no previous HIV infection
Show all 10Show fewer
- no previous nervous system
- no previous liver failure
- no previous nephrotic syndrome
- not passed more than 48 hours from diagnose of acute respiratory failure
Who cannot join
- death at less than three days of enteral feeding administration
- extubation at less than three days of enteral feeding administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Enteral Feeding's Macronutrient Composition on Inflammatory Mediators, Oxidative Stress and Outcomes in Intensive Care Unit Patients With Acute Respiratory Failure
This study aimed to investigate the effect of enteral feeding's macronutrient composition on inflammatory mediators, oxidative stress and outcomes in Intensive Care Unit (ICU) patients with acute respiratory failure. In this double-blind randomized control trial, 42 patients of both sexes and diagnosed with acute respiratory failure in ICU that receive enteral feeding, will be randomly assigned to three groups of 14 each. First Intervention group; high-protein low-carbohydrate diet with high olive oil, the second intervention group; high-protein low-carbohydrate diet with high sunflower oil and control; high-protein kitchen formula. Intravenous levels of uric acid, high sensitive C-Reactive Protein (hs-CRP), Interleukin 6 (IL-6) and Total Antioxidant Capacity (TAC) measured at days 0 and 10. As well as, organ failure, duration of ventilation, length of ICU stay and mortality rates will be evaluated.
- Conditions
- Acute Respiratory Failure
- Being tested
- high-protein low-carbohydrate diet with high olive oil, high-protein low-carbohydrate diet with high sunflower oil
- Keywords
- acute respiratory failure, lung, enteral feeding, feeding composition, olive, high fat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-protein low-carbohydrate diet with high olive oilOther
high-protein low-carbohydrate diet with high sunflower oilOther
| Study group | Role | What they receive |
|---|---|---|
| high olive oli | Experimental | A high fat (45%) low carbohydrate (35%) enteral feeding will be administered to acute respiratory failure patients. The percentage of olive oil will be half of total fat. Receives: Other: high-protein low-carbohydrate diet with high olive oil |
| high sunflower oil | Experimental | A high fat (45%) low carbohydrate (35%) enteral feeding will be administered to acute respiratory failure patients. The total fat will be sunflower oil. Receives: Other: high-protein low-carbohydrate diet with high sunflower oil |
| kitchen formula | No intervention | A high protein kitchen diet for tube feeding will be administered to acute respiratory failure patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of ventilation
The number of days from the patient intubation to his/her extubation
Measured: The number of days at least 3, to which days that patient extubated
Secondary outcomes (4)
Levels of high sensitive C-Reactive Protein (hs-CRP) in patient's vein blood
Measured: 10 days
Levels of Total Antioxidant Capacity (TAC) in patient's vein blood
Measured: 10 days
Levels of uric acid in patient's vein blood
Measured: 10 days
Levels of Interleukin 6 (IL-6) in patient's vein blood
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startAug 2013
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahra Vahdat Shariatpanahi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zahra Vahdat Shariatpanahi, Shahid Beheshti University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421614
- Sponsor's protocol ID
- 054575
- Status last verified
- Nov 2015
- First submitted
- 7 Apr 2015
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enteral Feeding's Macronutrient Composition on Inflammatory Mediators, Oxidative Stress and Outcomes in Intensive Care Unit Patients With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT02421614
- Acronym / sponsor ID
- 054575
- Conditions
- Acute Respiratory Failure
- Keywords
- acute respiratory failure, lung, enteral feeding, feeding composition, olive, high fat
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Zahra Vahdat ShariatpanahiUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Apr 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.
This study aimed to investigate the effect of enteral feeding's macronutrient composition on inflammatory mediators, oxidative stress and outcomes in Intensive Care Unit (ICU) patients with acute respiratory failure. In this double-blind randomized control trial, 42 patients of both sexes and diagnosed with acute respiratory failure in ICU that receive enteral feeding, will be randomly assigned to three groups of 14 each. First Intervention group; high-protein low-carbohydrate diet with high olive oil, the second intervention group; high-protein low-carbohydrate diet with high sunflower oil and control; high-protein kitchen formula. Intravenous levels of uric acid, high sensitive C-Reactive Protein (hs-CRP), Interleukin 6 (IL-6) and Total Antioxidant Capacity (TAC) measured at days 0 and 10. As well as, organ failure, duration of ventilation, length of ICU stay and mortality rates will be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high olive oli | Experimental | Other: high-protein low-carbohydrate diet with high olive oilA high fat (45%) low carbohydrate (35%) enteral feeding will be administered to acute respiratory failure patients. The percentage of olive oil will be half of total fat. |
| high sunflower oil | Experimental | Other: high-protein low-carbohydrate diet with high sunflower oilA high fat (45%) low carbohydrate (35%) enteral feeding will be administered to acute respiratory failure patients. The total fat will be sunflower oil. |
| kitchen formula | No intervention | –A high protein kitchen diet for tube feeding will be administered to acute respiratory failure patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- enrolled in ICU
- age older than 18 years old
- need to be mechanically ventilation
- have enteral feeding
- no previous diabetes
Key exclusion criteria (2 listed)
- death at less than three days of enteral feeding administration
- extubation at less than three days of enteral feeding administration
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 |
|---|---|---|
| high-protein low-carbohydrate diet with high olive oil | Other | high olive oli |
| high-protein low-carbohydrate diet with high sunflower oil | Other | high sunflower oil |
Primary outcome
length of ventilation
Time frame: The number of days at least 3, to which days that patient extubated
The number of days from the patient intubation to his/her extubation
4 secondary outcomes
Levels of high sensitive C-Reactive Protein (hs-CRP) in patient's vein blood
Time frame: 10 days
Levels of Total Antioxidant Capacity (TAC) in patient's vein blood
Time frame: 10 days
Levels of uric acid in patient's vein blood
Time frame: 10 days
Levels of Interleukin 6 (IL-6) in patient's vein blood
Time frame: 10 days
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 22 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing high-protein low-carbohydrate diet with high olive oil and high-protein low-carbohydrate diet with high sunflower oil in people with Acute Respiratory Failure, run by Zahra Vahdat Shariatpanahi at 1 site in Iran.
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 10 inclusion and 2 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 22 Mar 2016. 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 Iran. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
length of ventilation (time frame: The number of days at least 3, to which days that patient extubated). 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 22 Mar 2016.