- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07634133
The Impact of Omega-3 Fatty Acid Supplementation on the Composition of Erythrocyte Membranes
The Impact of Omega-3 Fatty Acid Supplementation on the Composition of Erythrocyte and Neuromuscular System in Athletes
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Katowice, Poland, 40-065
- Academy of Physical Education in Katowice
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
**Inclusion Criteria:**
- Male participants aged 20-40 years.
- Apparently healthy individuals, as determined by medical history and self-reported health status.
- Physically active, engaging in regular physical activity at least 3 times per week for the previous 6 months.
- Following a mixed diet.
- Willingness to maintain habitual dietary and physical activity patterns throughout the study.
- Willingness to refrain from consuming dietary supplements other than those provided as part of the study.
**Exclusion Criteria:**
- Current use of dietary supplements within 4 weeks prior to enrollment.
- Following a low-carbohydrate, ketogenic, high-carbohydrate, vegetarian, or vegan diet.
- Presence of gastrointestinal disorders affecting nutrient absorption, including irritable bowel syndrome, inflammatory bowel disease, celiac disease, or other clinically significant gastrointestinal conditions.
- History of cardiovascular, metabolic, endocrine, hepatic, renal, neurological, or autoimmune diseases.
- Current use of medications known to affect lipid metabolism, inflammation, antioxidant status, or cognitive function.
- Known allergy or intolerance to study supplements or their ingredients.
- Participation in another clinical trial within the previous 3 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AL (Alpha-linolenic acid) supplementation
Participants were randomly assigned to the ALA supplementation group.
After 4 weeks of the supplementation, there was a 12-week wash-out period, after which the participants crossed over to the EPA /DHA group.
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The supplement will be administered in a dose of 4 capsules twice a day for 4 weeks.
Daily dose will contain 3500mg ALA.
|
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Experimental: EPA (eicosapentaenoic acid)/DHA (docosahexaenoic acid) supplementation
Participants were randomly assigned to the EPA/DHA supplementation group.
After 4 weeks of the supplementation, there was a 12-week wash-out period, after which the participants crossed over to the ALA group.
|
The supplement will be administered in a dose of 4 capsules twice a day for 4 weeks.
Each capsule will contain 330mg EPA and 220mgDHA.
Other Names:
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Placebo Comparator: Placebo supplementation
Participants were randomly assigned to the Placebo group.
After 4 weeks of the supplementation, there was a 12-week wash-out period, after which they repeated the placebo supplementation.
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The supplement will be administered in a dose of 4 capsules twice a day for 4 weeks.
One capsule will contain 550 mg of olive oil.
The placebo will be matched to the supplement in appearance.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Omega 3 index
Time Frame: 4-weeks
|
The Omega-3 Index (%) determines the content of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) relative to total fatty acids in erythrocyte membranes. It is expressed as a percentage and reflects long-term fatty acid intake. Unit of Measure: % |
4-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tensiomyography (TMG) Parameters
Time Frame: 4-weeks
|
2a.
Maximal Radial Displacement (Dm) Unit of Measure: mm 2b.
Contraction Time (Tc) Unit of Measure: ms 2c.
Delay Time (Td) Unit of Measure: ms 2d.
Sustain Time (Ts) Unit of Measure: ms 2e.
Half-Relaxation Time (Tr) Unit of Measure: ms Description: Muscle contractile properties assessed using tensiomyography (TMG-BMC system).
|
4-weeks
|
|
Corsi Block-Tapping Test - Unweighted Block Span
Time Frame: 4-weeks
|
Description: Maximum correctly reproduced sequence length in Corsi Block-Tapping Test. Unit of Measure: blocks |
4-weeks
|
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Corsi Block-Tapping Test - Block Time
Time Frame: 4 weeks
|
Description: Reaction time performance in visuospatial working memory assessed using Corsi Block-Tapping Test. Unit of Measure: ms |
4 weeks
|
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Corsi Block-Tapping Test - Reverse Span Score
Time Frame: 4 weeks
|
Description: Working memory performance assessed using reverse span condition of Corsi Block-Tapping Test. Unit of Measure: score |
4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Antioxidant Status (TAS)
Time Frame: 4 weeks
|
Description: Plasma total antioxidant status measured using Randox TAS kit. Unit of Measure: mmol/L |
4 weeks
|
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Malondialdehyde (MDA) Concentration
Time Frame: 4 weeks
|
Description: Plasma malondialdehyde concentration measured using thiobarbituric acid reactive substances method. Unit of Measure: nmol/mL |
4 weeks
|
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Superoxide Dismutase (SOD) Activity
Time Frame: 4 weeks
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Description: Activity of superoxide dismutase in red blood cell lysates measured using Randox kits. Unit of Measure: U/g Hb |
4 weeks
|
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Glutathione Peroxidase (GPx) Activity
Time Frame: 4 weeks
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Description: Activity of glutathione peroxidase in red blood cell lysates measured using Randox kits. Unit of Measure: U/g Hb |
4 weeks
|
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Body Mass
Time Frame: 4 weeks
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Description: Body mass measured using multi-frequency bioelectrical impedance analysis (InBody 770). Unit of Measure: kg |
4 weeks
|
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Body Fat Percentage
Time Frame: 4 weeks
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Description: Body fat percentage measured using multi-frequency bioelectrical impedance analysis (InBody 770). Unit of Measure: % |
4 weeks
|
Collaborators and Investigators
Investigators
- Study Director: Małgorzata Magdalena Michalczyk, Phd, Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
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
Keywords
Other Study ID Numbers
- 4-II/2024
- 2024/53/B/NZ7/02257 (Other Grant/Funding Number: Narodowe Centrum Nauki)
- RID/SP/0053/2024/01 (Other Identifier: The Regional Initiative of Excellence programme)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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