NCT06294067

A Dose Response Investigation of Docosahexaenoic Acid (DHA)

Name: Clinical Trial NCT06294067
Creator: University of Toronto
Keywords: Nutrition, Healthy, docosahexaenoic acid (DHA), dietary supplement, clinical trial, Canada

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 Biomarker

University of Toronto·ClinicalTrials.gov·dietary supplementRecruiting

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Study focus

Disease/Condition: Nutrition, Healthy
Drug/Device/Intervention: docosahexaenoic acid (DHA)
Study type: Interventional
Intervention type: dietary supplement

Sponsor & location

Primary sponsor: University of Toronto
Location: Toronto, Canada

Timeline & enrollment

Phase: N/A
Start date: Mar 01, 2024
End date: Sep 01, 2025
Enrollment: 72 participants

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 (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.

ICD-10 classifications

Seeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmfulMalnutritionObesitySequelae of malnutrition and other nutritional deficienciesNutritional deficiency, unspecified

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06294067
Type: Non-Device Trial

About this record

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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