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A Dose Response Investigation of Docosahexaenoic Acid (DHA)

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clinicaltrials.gov/study/NCT06294067
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT062940670
Trial Recruitment Size
720
Trial Sponsor
University of Toronto
University of Toronto
0
Clinical Trial Start Date
2024
0
Primary Completion Date
2025
0
Study Completion Date
2025
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Basic Science0
Intervention Type
Dietary Supplement0
Interventional Trial Phase
Not Applicable0
Official Name
A Double Blinded Randomized Control Trial to Aid in Determining the Dose Dependent Relationship of Docosahexaenoic Acid (DHA) on Eicosapentaenoic Acid (EPA) Feedback Inhibition Using Carbon 13 as a Biomarker0
Last Updated
March 5, 2024
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Double0
Masked Party
Investigator0
Participant0

Other attributes

Intervention Treatment
docosahexaenoic acid (DHA)0
soybean oil placebo0
Study 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 (δ13C) 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 δ13C 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.

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