Endothelial DysfunctionNCT06271434
Effects of Krill Oil on Intestinal Integrity Markers in Elite Rowers.
A study testing THYROX (Atlantic krill oil in people with Endothelial Dysfunction, run by Poznan University of Physical Education.
Trial summary
The study aims to check the influence of krill oil on markers of intestinal injury and intoxication. Research group: the research will be conducted in a homogeneous group of professional rowers (N=30), all competitors qualified for the Polish Youth Rowing Team, aged 18 - 24. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- THYROX (Atlantic krill oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 23 Mar 2024to 24 Jun 2024
- 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- training experience of a minimum of five years,
- minimum training time per week 240 minutes,
- all competitors qualified for the Polish Youth Rowing Team,
- completing a food diary,
- finishing 2000m ergometer test.
Who cannot join
- Probiotics, prebiotics and antibiotic therapy within the last three months,
- dietary regime,
- gastrointestinal diseases,
- lactose intolerance.
Trial locations and contacts
No sites are listed yet.
Anna Skarpańska-Stejnborn, professor contact
About this study
Official title: Krill Oil Supplementation and Its Effect on Intestinal Permeability Markers in Elite Rowers.
The study aims to check the influence of krill oil on markers of intestinal injury and intoxication.
Research group: the research will be conducted in a homogeneous group of professional rowers (N=30), all competitors qualified for the Polish Youth Rowing Team, aged 18 - 24. The sample size was confiremed in statistical analyses.
Read more
Rowing performance test will be conducted at the beginning and at the end of the training camp. Participants will perform a test on a rowing ergometer (Concept II, USA); each subject will have to cover a distance of 2000 m in the shortest possible time which is the distance starting in rowing competitions. The results of both tests will be considered in the selection for the championship team; therefore, athletes will be well motivated to perform both tests with maximum effort.
Hypotesis:
The krill oil will infleunce the gut barier integrity.
Read the detailed description
All competitors will be randomly divided into two groups (double-blind):
- supplemented (n = 15), who will receive one capsule of THYROX (Atlantic krill oil) four times a day.
- control (n = 15) receiving placebo. The supplementation period will be six weeks.
Characteristic of the supplement:
THYROX (Atlantic krill oil). The daily recommended intake of krill oil is 2000 mg, which includes 350 mg of omega-3 fatty acids, 240 mg of EPA, 110 mg of DHA, 800 mg of phospholipids, and 200 mg of astaxanthin.
Placebo will be produced by MLB Bitrade Sp. z o.o., Poznan.
Measurement: The project contractors will measure all parameters using the available equipment in the ZWKF laboratory in Gorzów Wielkopolski and commercial assay kits.
Polyethylene clotting activator tubes (9 ml) will be centrifuged to separate the morphotic elements from the serum using a centrifuge (3000 rpm for 10 min). The serum will be pipetted into several Eppendorf tubes, then frozen (temp. -80 °C). All the following biochemical parameters will be determined from the extracted serum:
using the ELISA method by the test manufacturer's instructions. The designations include the flowing parameters:
a food diary will be filled day before the study and in the morning before the test, markers of gut injury: I-FABP (intestinal fatty acid binding protein), CLDN-3 (claudin 3) intoxication: LBP (lipopolysaccharide binding protein) stress hormones: ACTH and cortisol will be determined using the colourimetric method on the SPECTROstar Nano reader.
The lactate (La) concentration will be determined from the capillary blood immediately after collection using a commercially available kit (Diaglobal, Germany).
- Conditions
- Endothelial Dysfunction
- Being tested
- THYROX (Atlantic krill oil, Placebo
- Keywords
- endotoxin, gastrointestinal symtoms, gut permeability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THYROX (Atlantic krill oilDietary supplement
The daily content of krill oil is 2000 mg, including omega-3 fatty acids 350 mg, EPA - 240 mg, DHA- 110 mg, phospholipids - 800 mg, astaxanthin 200 mg.
PlaceboDietary supplement
The control capsules will be made of olive oil of equal size and color.
| Study group | Role | What they receive |
|---|---|---|
| Supplemented | Experimental | (n = 15), who will receive one capsule of a supplement called THYROX (Atlantic krill oil) four times a day. The daily content of krill oil is 2000 mg, including omega-3 fatty acids 350 mg, EPA - 240 mg, DHA - 110 mg, phospholipids - 800 mg, astaxanthin 200 mg.
The supplementation period will be six weeks. Intervention: Drug: THYROX (Atlantic krill oil). Receives: Dietary Supplement: THYROX (Atlantic krill oil |
| Control | Experimental | receiving placebo Intervention: Drug: Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
I-FABP (intestinal fatty acid binding protein)
gut injury (enterocyte)
Measured: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
CLDN-3
gut injury (tight junction)
Measured: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
LBP (lipopolysaccharide binding protein)
endotoxin
Measured: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
Catechyloamines, cortisol
stress hormones
Measured: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
CD14
endotoxin
Measured: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
Secondary outcomes (1)
Food intake
macro and micronutrients, fluids
Measured: day before the test, morning before the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start23 Mar 2024 (estimated)
- Primary completion24 Jun 2024 (estimated)
- Study completion24 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All competitors will be randomly divided into two groups (double-blind): A. supplemented (n = 15), who will receive one capsule of a supplement called THYROX (Atlantic krill oil) four times a day. B. control (n = 15) receiving placebo. The supplementation period will be six weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Skarpańska-S, professor, Study director, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271434
- Sponsor's protocol ID
- Olej z kryla/jelita
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Krill Oil Supplementation and Its Effect on Intestinal Permeability Markers in Elite Rowers.
- ClinicalTrials.gov ID
- NCT06271434
- Acronym / sponsor ID
- Olej z kryla/jelita
- Conditions
- Endothelial Dysfunction
- Keywords
- endotoxin, gastrointestinal symtoms, gut permeability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 23 Mar 2024 (estimated)
- Primary completion
- 24 Jun 2024 (estimated)
- Study completion
- 24 Jun 2024 (estimated)
- First posted
- 21 Feb 2024 (actual)
- 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 study aims to check the influence of krill oil on markers of intestinal injury and intoxication.
Research group: the research will be conducted in a homogeneous group of professional rowers (N=30), all competitors qualified for the Polish Youth Rowing Team, aged 18 - 24. The sample size was confiremed in statistical analyses.
Rowing performance test will be conducted at the beginning and at the end of the training camp. Participants will perform a test on a rowing ergometer (Concept II, USA); each subject will have to cover a distance of 2000 m in the shortest possible time which is the distance starting in rowing competitions. The results of both tests will be considered in the selection for the championship team; therefore, athletes will be well motivated to perform both tests with maximum effort.
Hypotesis:
The krill oil will infleunce the gut barier integrity.
Detailed description
All competitors will be randomly divided into two groups (double-blind):
- supplemented (n = 15), who will receive one capsule of THYROX (Atlantic krill oil) four times a day.
- control (n = 15) receiving placebo. The supplementation period will be six weeks.
Characteristic of the supplement:
THYROX (Atlantic krill oil). The daily recommended intake of krill oil is 2000 mg, which includes 350 mg of omega-3 fatty acids, 240 mg of EPA, 110 mg of DHA, 800 mg of phospholipids, and 200 mg of astaxanthin.
Placebo will be produced by MLB Bitrade Sp. z o.o., Poznan.
Measurement: The project contractors will measure all parameters using the available equipment in the ZWKF laboratory in Gorzów Wielkopolski and commercial assay kits.
Polyethylene clotting activator tubes (9 ml) will be centrifuged to separate the morphotic elements from the serum using a centrifuge (3000 rpm for 10 min). The serum will be pipetted into several Eppendorf tubes, then frozen (temp. -80 °C). All the following biochemical parameters will be determined from the extracted serum:
using the ELISA method by the test manufacturer's instructions. The designations include the flowing parameters:
a food diary will be filled day before the study and in the morning before the test, markers of gut injury: I-FABP (intestinal fatty acid binding protein), CLDN-3 (claudin 3) intoxication: LBP (lipopolysaccharide binding protein) stress hormones: ACTH and cortisol will be determined using the colourimetric method on the SPECTROstar Nano reader.
The lactate (La) concentration will be determined from the capillary blood immediately after collection using a commercially available kit (Diaglobal, Germany).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All competitors will be randomly divided into two groups (double-blind): A. supplemented (n = 15), who will receive one capsule of a supplement called THYROX (Atlantic krill oil) four times a day. B. control (n = 15) receiving placebo. The supplementation period will be six weeks.
| Arm | Type | Receives |
|---|---|---|
| Supplemented | Experimental | Dietary Supplement: THYROX (Atlantic krill oil(n = 15), who will receive one capsule of a supplement called THYROX (Atlantic krill oil) four times a day. The daily content of krill oil is 2000 mg, including omega-3 fatty acids 350 mg, EPA - 240 mg, DHA - 110 mg, phospholipids - 800 mg, astaxanthin 200 mg. The supplementation period will be six weeks. Intervention: Drug: THYROX (Atlantic krill oil). |
| Control | Experimental | Dietary Supplement: Placeboreceiving placebo Intervention: Drug: Placebo |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- training experience of a minimum of five years,
- minimum training time per week 240 minutes,
- all competitors qualified for the Polish Youth Rowing Team,
- completing a food diary,
- finishing 2000m ergometer test.
Key exclusion criteria (4 listed)
- Probiotics, prebiotics and antibiotic therapy within the last three months,
- dietary regime,
- gastrointestinal diseases,
- lactose intolerance.
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 |
|---|---|---|
| THYROX (Atlantic krill oilThe daily content of krill oil is 2000 mg, including omega-3 fatty acids 350 mg, EPA - 240 mg, DHA- 110 mg, phospholipids - 800 mg, astaxanthin 200 mg. | Dietary supplement | Supplemented |
| PlaceboThe control capsules will be made of olive oil of equal size and color. | Dietary supplement | Control |
Primary outcome
I-FABP (intestinal fatty acid binding protein)
Time frame: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
gut injury (enterocyte)
CLDN-3
Time frame: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
gut injury (tight junction)
LBP (lipopolysaccharide binding protein)
Time frame: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
endotoxin
Catechyloamines, cortisol
Time frame: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
stress hormones
CD14
Time frame: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.
endotoxin
1 secondary outcome
Food intake
Time frame: day before the test, morning before the test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Anna Skarpańska-Stejnborn, professor contact
Anna Skarpańska-S, professor study director
Poznan University of Physical Education
Questions about this trial
What is this clinical trial studying?
A study testing THYROX (Atlantic krill oil in people with Endothelial Dysfunction, run by Poznan University of Physical Education.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Mar 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanna Dziewiecka, Msc (606880282 ext. +48, hannadziewiecka@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
I-FABP (intestinal fatty acid binding protein) (time frame: Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.). The study lists 5 primary outcomes in all. 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 18 Mar 2024.