Exploring Sustainable Alternatives to Marine Oils With Echium and Ahiflower Oils
NCT ID: NCT07289919
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
15 participants
INTERVENTIONAL
2025-05-26
2026-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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Crossover Intervention Sequence 1
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.
Echium oil
Participants consume 15 g/day of Echium oil, incorporated into meals, during one 8-week phase.
Ahiflower oil
Participants consume 15 g/day of Ahiflower® oil, incorporated into meals, during one 8-week phase.
EPA capsules
Participants consume three EPA capsules daily (totaling 2.34 g/day), taken with meals, during one 8-week phase.
Crossover Intervention Sequence 2
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.
Echium oil
Participants consume 15 g/day of Echium oil, incorporated into meals, during one 8-week phase.
Ahiflower oil
Participants consume 15 g/day of Ahiflower® oil, incorporated into meals, during one 8-week phase.
EPA capsules
Participants consume three EPA capsules daily (totaling 2.34 g/day), taken with meals, during one 8-week phase.
Crossover Intervention Sequence 3
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.
Echium oil
Participants consume 15 g/day of Echium oil, incorporated into meals, during one 8-week phase.
Ahiflower oil
Participants consume 15 g/day of Ahiflower® oil, incorporated into meals, during one 8-week phase.
EPA capsules
Participants consume three EPA capsules daily (totaling 2.34 g/day), taken with meals, during one 8-week phase.
Interventions
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Echium oil
Participants consume 15 g/day of Echium oil, incorporated into meals, during one 8-week phase.
Ahiflower oil
Participants consume 15 g/day of Ahiflower® oil, incorporated into meals, during one 8-week phase.
EPA capsules
Participants consume three EPA capsules daily (totaling 2.34 g/day), taken with meals, during one 8-week phase.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Inclusion criteria will include individuals of both sexes, aged 18 to 30 years, without contraindications for using fish oil or vegetable oil supplements. Women must not be pregnant or breastfeeding.
Exclusion Criteria:
* will include vegetarianism or veganism; the use of triglyceride-lowering medications or dietary supplements; consumption of fish oil or other n-3 or n-6 PUFA supplements/drugs within one month before the trial; consumption of fatty fish (salmon, herring, mackerel, albacore tuna, or sardines) more than twice a month in the month before the trial; and unwillingness to avoid PUFA supplements and seafood throughout the study period. Additional exclusions will include severe heart failure, active severe liver disease, planned coronary intervention or surgery, history of acute or chronic pancreatitis, known hypersensitivity to fish, shellfish, or capsule ingredients, and autoimmune diseases requiring immunosuppressive therapy or current systemic corticosteroid use. Other exclusion criteria will encompass active neoplasms requiring surgery, chemotherapy, or radiation within the past 12 months (patients who underwent curative surgery without further treatment in the last 12 months may be eligible); inflammatory bowel disease or chronic diarrhea; significant non-transient hematological abnormalities; renal dysfunction; severe liver disease; inability to provide informed consent; participation in another clinical trial involving an investigational agent within the past 90 days; malabsorption syndrome; recent drug or alcohol abuse; atrial fibrillation; or bleeding disorders. Adherence to the prescribed dosage will be assessed by tracking the residual oil sachets and capsules returned by participants. If fewer than 80% of the doses over the full study period are consumed, participants will be classified as non-compliant, and their data will be excluded from efficacy analyses.
18 Years
30 Years
ALL
Yes
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Inar Castro Erger
Full Professor
Locations
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Faculty of Pharmaceutical Sciences, University of São Paulo (USP)
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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85126524.0.0000.0067
Identifier Type: -
Identifier Source: org_study_id