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Omega-3 Fatty Acid

DHA1 - 100mg of DHA/d 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

Awards & highlights

DRI-DHA Trial 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.Check my eligibility

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.See study design

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.

DRI-DHA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in omega-3 polyunsaturated fatty acid (n-3 PUFA) blood levels

Secondary outcome measures

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 outcome measures

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

DRI-DHA 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of TorontoLead Sponsor

690 Previous Clinical Trials

1,019,571 Total Patients Enrolled

Unity Health TorontoOTHER

540 Previous Clinical Trials

447,708 Total Patients Enrolled

Richard P Bazinet, PhDPrincipal InvestigatorUniversity of Toronto

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the inclusion criteria for this medical study encompass individuals who are 60 years of age or older?

"Individuals between the ages of 18 and 50 are eligible for participation in this research study. There are separate trials available for individuals under 18 years old and those aged over 65, with a total of 14 trials for the former group and 33 for the latter."

Answered by AI

Is there a possibility for me to partake in this clinical trial?

"This clinical study is enrolling 72 participants aged between 18 and 50 who maintain a nutritious diet. Eligible candidates must adhere to being healthy vegans or vegetarians refraining from meat and fish consumption."

Answered by AI

Are participants still being accepted for this clinical trial?

"According to the details available on clinicaltrials.gov, this trial is currently in search of eligible participants. Originally registered on March 1st, 2024, with the most recent update dated March 25th, 2024."

Answered by AI

What is the number of participants currently enrolled in this clinical study?

"Affirmative. The details on clinicaltrials.gov highlight the ongoing recruitment for this trial. Initially shared on March 1st, 2024, and last revised on March 25th, 2024, the study aims to enroll a total of 72 participants at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Dose Response Investigation of Docosahexaenoic Acid (DHA)

Richard Bazinet 2024. "A Dose Response Investigation of Docosahexaenoic Acid (DHA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06294067.

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