- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07276113
Enriched Eggs as a Sustainable Approach to Enhance Omega-3 Status in Elite Athletes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study hypothesis: Consuming omega-3 enriched eggs (compared to control) will (1) increase omega-3 index whilst also (2) improving subjective markers of recovery and other health parameters.
Aims & objective:
Overall aim: To investigate the impact of consuming omega-3 enriched eggs blood fatty acid profile among elite level athletes who do not reach omega-3 index targets of 8%, compared to control. Secondary data collected will analyse the impact on health and recovery parameters.
Primary objective: To assess the effect of consuming omega-3 enriched eggs on blood fatty acid response (omega-3 index) in elite level athletes.
Secondary objective: To assess the effect of consuming omega-3 enriched eggs on subjective recovery markers using validated questionnaires (RESTQ-Sport-36, appendix 1; Acute Recovery & Stress Scale, appendix 2) and other health parameters including resting heart rate and blood pressure.
Recruitment Participants will be recruited from Sport Ireland Institute of Sport (SII). SII are partners for this PhD and will provide access for recruitment to those teams/ athletes based in Dublin. Further recruitment will be open to teams across the island of Ireland where potential participants are competing at the highest level within that sport. All relevant permissions will be obtained before commencing any recruitment strategy. All recruitment will initially require approval from the Head of Performance for that sport, this will allow for the researcher to provide athletes with an information sheet, screening questionnaire and consent form. Secondary recruitment will be via a poster which will be put up around the campus. This recruitment will be provided approval by relevant individuals in SII and QUB. The poster will have a QR code which links the interested party to the participant information sheet and screening questionnaire.
Primary objective data collection:
Participants from both omega-3 enriched group and control group will provide a dried blood spot at week 0 (before starting intervention) and post 8-week intervention. The first step is to increase blood flow to the hands; this is done by asking the participant to wash their hands in warm water. The tip of the index finger is prepared with an antibacterial wipe, and this is allowed to dry unassisted. A lancet is then used to draw blood with the first show of blood being wiped away with gauze. The finger is gently squeezed, allowing a blood drop to form. The blood drop is allowed to drop onto the designated spot of the collection card. The collection cards are pre-treated with a proprietary antioxidant treatment called OxyStop, this prevents oxidative loss of PUFAs. The sample is allowed to dry for a few minutes before being sent the same day to a commercial laboratory for analysis (OmegaQuant, University of Stirling, GB).
Co-investigators are familiar with collecting OmegaQuant blood samples through previous professional experience.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dublin
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Dublin, Dublin, Ireland, D15 Y52H
- Sport Ireland Institute
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-
-
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Tyrone
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Omagh, Tyrone, United Kingdom, BT70 2EH
- Garvaghey Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Participants must be elite level female athletes (tier 4 or 5)
Exclusion Criteria:
- Non-smokers
- Must not be taking statins to lower LDL cholesterol levels.
- Must not have high blood pressure (systolic >140/ diastolic >90mmHg)
- Participants must remain injury free (not miss training >1week)
- Baseline omega-3 index of <8%
- Currently include eggs as part of their habitual diet.
- Participants must be willing to consume 14 eggs per week for 8 weeks.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
omega-3 enriched egg (14 eggs weekly for 8 weeks, ~250mg DHA daily).
|
omega-3 enriched eggs
|
|
Placebo Comparator: Control
Non enriched egg group (14 eggs per week for 8 weeks)
|
non-omega-3 enriched eggs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
omega-3 index
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne Nugent, Doctorate, Queens University Belfast
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MHLS 23_68
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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