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This randomized, single-blind, crossover clinical trial aims to evaluate Echium oil and Ahiflower® oil as sustainable, plant-based alternatives to marine oils for omega-3 supplementation. Although fish oil is the primary dietary source of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), its use as a dietary supplementation presents several drawbacks, including high cost, potential contamination, limited global supply, and sustainability concerns. Echium and Ahiflower oils are naturally rich in stearidonic acid (SDA), a metabolic intermediate that bypasses the rate-limiting Δ6-desaturase step in the omega-3 pathway, potentially enhancing the conversion to EPA.
Fifteen participants will undergo three 8-week intervention phases-Echium oil (15 g/day), Ahiflower oil (15 g/day), or EPA capsules (2.34 g/day)-separated by four-week washout periods. Blood samples will be collected before and after each phase to measure fatty acid profiles in plasma, plasma fractions, and erythrocytes using GC-MS. Anthropometric and biochemical parameters will also be assessed. The study seeks to determine whether SDA-rich plant oils can effectively increase EPA levels in humans and potentially reduce the reliance on marine oils for cardiovascular health benefits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crossover Intervention Sequence 1 | Experimental | All participants will receive all three interventions (Echium oil, Ahiflower® oil, and EPA capsules) in a randomized crossover sequence. Each intervention period lasts 8 weeks, followed by a 4-week washout period. Participants rotate through all treatments, ensuring within-subject comparison. In this sequence, participants begin with Echium oil, transition to EPA capsules, and complete the cycle with Ahiflower oil. |
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| Crossover Intervention Sequence 2 | Experimental | All participants will receive all three interventions (Echium oil, Ahiflower® oil, and EPA capsules) in a randomized crossover sequence. Each intervention period lasts 8 weeks, followed by a 4-week washout period. Participants rotate through all treatments, ensuring within-subject comparison. In this sequence, participants begin with Ahiflower oil, transition to Echium oil, and complete the cycle with EPA capsules. |
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| Crossover Intervention Sequence 3 | Experimental | All participants will receive all three interventions (Echium oil, Ahiflower® oil, and EPA capsules) in a randomized crossover sequence. Each intervention period lasts 8 weeks, followed by a 4-week washout period. Participants rotate through all treatments, ensuring within-subject comparison. In this sequence, participants begin with EPA capsules, transition to Ahiflower oil, and complete the cycle with Echium oil. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echium oil | Dietary Supplement | Participants consume 15 g/day of Echium oil, incorporated into meals, during one 8-week phase. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in EPA and DHA concentrations in blood fractions | EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) concentrations will be determined from blood fractions (plasma, plasma subfractions, and erythrocytes). Lipids will be extracted and derivatized to obtain fatty acid methyl esters (FAMEs), which will then be analyzed by gas chromatography-mass spectrometry (GC-MS). Measurements will be performed at baseline and after each 8-week intervention phase (Echium oil, Ahiflower® oil, and EPA capsules) to assess the efficiency of omega-3 conversion and incorporation under each supplementation condition | Baseline and after each 8-week intervention phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Pharmaceutical Sciences, University of São Paulo (USP) | São Paulo | São Paulo | 05508-000 | Brazil |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Ahiflower oil | Dietary Supplement | Participants consume 15 g/day of Ahiflower® oil, incorporated into meals, during one 8-week phase. |
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| EPA capsules | Dietary Supplement | Participants consume three EPA capsules daily (totaling 2.34 g/day), taken with meals, during one 8-week phase. |
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| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |