A Dose Response Investigation of Docosahexaenoic Acid (DHA) - Trial NCT06294067
Access comprehensive clinical trial information for NCT06294067 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Toronto and is currently Recruiting. The study focuses on Nutrition, Healthy. Target enrollment is 72 participants.
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Study Focus
Sponsor & Location
University of Toronto
Timeline & Enrollment
N/A
Mar 01, 2024
Sep 01, 2025
Primary Outcome
Changes in omega-3 polyunsaturated fatty acid (n-3 PUFA) blood levels
Summary
Docosahexaenoic acid (DHA) is an omega-3 polyunsaturated fatty acid (n-3 PUFA), commonly
 consumed from fish, that regulates many critical functions within the body including the
 brain, eye, and heart. While the metabolic precursor to DHA, alpha-linolenic acid (ALA) is
 considered nutritionally essential and has a set Dietary Reference Intake (DRI), DHA has not
 yet been deemed essential and does not have a set DRI. Currently, research suggests an intake
 range of dietary DHA to be anywhere from 0 to over 500mg/d. The aim of our study is to
 further investigate a feedback mechanism or accumulation that occurs with eicosapentaenoic
 acid (EPA) as a result of increased dietary DHA to provide insight for potential Recommended
 Dietary Intake (RDI) values.
 
 Hypothesis: The dietary DHA dose at which blood EPA levels increase is the point at which
 elongation slows, indicating a significant negative feedback pathway is present.
 
 Objectives: 1: To determine the dose-response for DHA to increase blood EPA levels in a mixed
 vegetarian and vegan population. 2: Investigate the DHA dose and time at dose that increases
 EPA using natural abundance delta carbon-13 (ฮด13C) as a tracer. 3: To measure DHA turnover
 and loss rates. 4: Provide data for exploratory analyses related to PUFA metabolism and the
 effect of DHA on disease related biomarkers.
 
 Method: During an 8-week trial, 72 healthy vegan or vegetarian males and females (18-50
 years) will be supplemented with 1 of 6 algal-oil based DHA doses: 0, 100, 200, 400, 800 or
 1000 mg/d. Blood will be collected at days 0, 3, 7, 14, 28 and 56 and will be analyzed for
 changes in blood EPA levels as the primary outcome and plasma ฮด13C EPA signature as the
 secondary outcome.
 
 Significance: Investigating this negative feedback pathway is of great importance in
 providing evidence to support n-3 PUFA DRIs. EPA and DHA are ecologically sensitive with
 their major source coming from unsustainably farmed fish stocks and having a set DRI may help
 to limit the overconsumption of these nutrients.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06294067
Non-Device Trial