Exploring Sustainable Alternatives to Marine Oils With Echium and Ahiflower Oils

NCT07289919 | Active Not Recruiting

• 1 other identifier: 85126524.0.0000.0067
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular (CV) Risk; Atheroscleroses; Inflamation; Omega 3 Fatty Acids; Supplement

Keywords

Omega - 3 fatty acids; stearidonic acid; fish oil; Echium oil; Ahiflower oil; Humans; Crossover

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Dietary Supplement: Echium oil; Dietary Supplement: Ahiflower oil; Dietary Supplement: EPA capsules

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.

Dietary Supplement: Echium oil; Dietary Supplement: Ahiflower oil; Dietary Supplement: EPA capsules

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.

Dietary Supplement: Echium oil; Dietary Supplement: Ahiflower oil; Dietary Supplement: EPA capsules

Interventions

EPA capsules DIETARY_SUPPLEMENT

Participants consume three EPA capsules daily (totaling 2.34 g/day), taken with meals, during one 8-week phase.

Also known as: Omega-3, IPE

Crossover Intervention Sequence 1; Crossover Intervention Sequence 2; Crossover Intervention Sequence 3

Echium oil DIETARY_SUPPLEMENT

Participants consume 15 g/day of Echium oil, incorporated into meals, during one 8-week phase.

Also known as: seed oil from Echium plantagineum

Crossover Intervention Sequence 1; Crossover Intervention Sequence 2; Crossover Intervention Sequence 3

Ahiflower oil DIETARY_SUPPLEMENT

Participants consume 15 g/day of Ahiflower® oil, incorporated into meals, during one 8-week phase.

Also known as: Buglossoides arvensis, Lithospermum arvense, corn gromwell

Crossover Intervention Sequence 1; Crossover Intervention Sequence 2; Crossover Intervention Sequence 3

Eligibility Criteria

• Age: 18 Years - 30 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Faculty of Pharmaceutical Sciences, University of São Paulo (USP)

São Paulo, São Paulo, 05508-000, Brazil

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: May 26, 2025
• Primary Completion: March 5, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-11

Locations

BR (1)