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Omega-3 Fatty Acid

DHA for Healthy Nutrition (DRI-DHA Trial)

N/A
Recruiting
Led By Richard P Bazinet, PhD
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks

Summary

"This trial aims to study the effects of different doses of DHA (an omega-3 fatty acid found in fish) on blood EPA levels in vegan and vegetarian individuals. The researchers want to determine if

Who is the study for?
This trial is for healthy vegans or vegetarians aged 18-50 who don't eat meat or fish. It's designed to understand how different doses of DHA, an omega-3 fatty acid from algae oil, affect blood levels of another omega-3 called EPA.
What is being tested?
Participants will take one of six different daily doses of DHA (0, 100, 200, 400, 800 or 1000 mg) over eight weeks. The study aims to see at what dose and time frame the body's EPA levels change and how quickly DHA is processed in the body.
What are the potential side effects?
DHA is generally considered safe with few side effects; however, some may experience mild digestive discomfort or a fishy aftertaste. High doses could potentially interfere with blood clotting or immune function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in omega-3 polyunsaturated fatty acid (n-3 PUFA) blood levels
Secondary study objectives
Changes in the delta carbon 13 (δ13C) n-3 PUFA signatures
Measure of n-3 LC PUFA half-lives
Measure of n-3 LC PUFA turnover rates
Other study objectives
Changes in cardiovascular disease (CVD) biomarkers (BMI in kg/m^2)
Changes in cardiovascular disease (CVD) biomarkers (Waist circumference in cm/inch)
Changes in cardiovascular disease (CVD) biomarkers (blood lipid profile changes in mmol/L)
+8 more

Trial Design

6Treatment groups
Active Control
Placebo Group
Group I: DHA1 - 100mg of DHA/dActive Control1 Intervention
DHA1 participants will take 100mg/d of DHA. As the DHA supplements are 200mg of DHA per capsule the participants here will take one 200mg capsule every other day and the rest of the capsules will be placebos.
Group II: DHA5 - 1000mg of DHA/dActive Control1 Intervention
DHA5 participants will take five 200mg capsules of DHA and no placebos per day.
Group III: DHA2 - 200mg of DHA/dActive Control1 Intervention
DHA2 participants will take one 200mg capsule of DHA and 4 placebos per day.
Group IV: DHA3 - 400mg of DHA/dActive Control1 Intervention
DHA3 participants will take two 200mg capsules of DHA and 3 placebos per day.
Group V: DHA4 - 800mg of DHA/dActive Control1 Intervention
DHA4 participants will take four 200mg capsules of DHA and 1 placebo per day.
Group VI: DHA0 - 0mg of DHA/dPlacebo Group1 Intervention
DHA0 participants are in the placebo group and will take 5 soybean oil based capsules per day and will not receive any DHA. Every group takes 5 capsules per day to maintain blinding.

Find a Location

Who is running the clinical trial?

University of TorontoLead Sponsor
717 Previous Clinical Trials
1,042,345 Total Patients Enrolled
Unity Health TorontoOTHER
556 Previous Clinical Trials
454,334 Total Patients Enrolled
Richard P Bazinet, PhDPrincipal InvestigatorUniversity of Toronto
~22 spots leftby Apr 2025
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