Observing Metabolism of EPA With Consideration of Genetics And Sex
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EPA 2.4g/day.
- Who it may be relevant to
- Registry conditions: Healthy, Omega 3, Metabolism, Lipids. Basic parameters: 18 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Determining Contribution of Sex and Genetics to DHA Synthesis Rates Over 12 Weeks of EPA Supplementation in Healthy Individuals
Overview
The goal of this clinical study is to learn how fast EPA is converted to other molecules, including DHA, with consideration of biological sex and genetics in healthy humans. The main questions it aims to answer are: * How fast is EPA converted to DHA in blood, and is the conversion rate affected by sex and a specific genotype we previously identified? * How do sex and the specific genotypes affect blood DHA levels and other products of DHA in response to dietary EPA? * How fast does dietary EPA replace blood EPA and other omega-3 fatty acids, and is the rate affected by sex and genotype? Participants will be asked to take EPA supplements for 12 weeks and provide a series of venous blood samples over the study duration.
Interventions
- Dietary supplement EPA 2.4g/day
EPA from fish oil will be supplemented to an equal number of males and females for 12 weeks.
Primary outcome measures
- Plasma DHA synthesis/turnover rates [Time frame: Day 0, 3, 7, 14, 28, 56, 84]
Secondary outcome measures (5)
- Changes in plasma DHA concentrations (nmol/ml) [Time frame: Baseline and 12 weeks]
- Plasma EPA turnover rates (nmol/ml/day) [Time frame: Day 0, 3, 7, 14, 28, 56, 84]
- Plasma DPAn-3 synthesis/turnover rates (nmol/ml/day) [Time frame: Day 0, 3, 7, 14, 28, 56, 84]
- Changes in PUFA derived eicosanoid/docosanoid levels [Time frame: Baseline, 4 weeks and 12 weeks]
- Plasma half-lives of EPA and downstream n-3 PUFAs [Time frame: Over 12 weeks]
Eligibility criteria
Inclusion criteria
- BMI between 18.5- 30 kg/m2
- healthy
Exclusion criteria
- Consumption of fish/seafood or EPA/DHA-enriched foods currently or within the previous 6 months
- Consumption of any supplements containing ALA/EPA/DHA currently or within the previous 6 months
- Allergies to any component of the study supplement (fish, gelatin etc.)
- BMI <18.5 kg/m² or >30 kg/m²
- Women who are pregnant, breastfeeding or planning on becoming pregnant
- Diagnosis with chronic or communicable diseases
- Prescription of chronic pharmacological medications (except for oral contraceptives)
- High blood pressure (systolic or diastolic blood pressure above 130 or 80mmHg, respectively)
- Hypertriglyceridemia (serum > or = 1.69 mmol/l)
- Hypercholesterolemia (serum LDL-C > or =5 mmol/l)
- Anticipated changes in lifestyle within the next 4 months
- Smoking
- Heavy alcohol use (>3 drinks/day)
- Major surgery in the last six months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Canada · 1 center
- Clinical Nutrition and Risk Factor Modification Centre — Toronto
Identifiers
NCT: NCT06975241 · 00048186