Effects of the Consumption of a Supplement Rich in Docosahexaenoic Acid (DHA) From Algae

January 13, 2023 updated by: M Pilar Vaquero, National Research Council, Spain

"Diseño y Validación en Humanos de un Nuevo Complemento Alimenticio Rico en Ácido Docosahexaenoico (DHA) Procedente de Algas"

Vegetarian diets are increasing worldwide. To prevent nutritional deficiencies, supplementation with nutrients that are only present in animal food can be needed. In relation to fatty acids, vegetarian diets involve low intake of omega-3 polyunsaturated fatty acids (n-3 PUFA) and low blood levels of the long-chain n-3 derivatives, whose main dietary sources are fish and shellfish, particularly the levels of docosahexaenoic acid (DHA), which has important health benefits, are low.

In this regard, validation of supplements rich in the n-3 fatty acid DHA that are not obtained from fish is needed, thus the study will test the bioavailability and metabolic effects of a DHA supplement form algae.

The study will be conducted on the effects of the DHA supplement versus placebo in vegetarian and non-vegetarian healthy adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • M.Pilar Vaquero

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult (age ≥18 and ≤45 years).
  • Healthy.
  • Women.
  • Men.
  • Participant following either a vegetarian diet during at least 6 months or following a omnivorous diet but consuming fish 2 times per week or less.

Exclusion Criteria:

  • Age <18 and >45 years old.
  • Pregnancy.
  • Diseases: liver diseases, gastric diseases, irritable bowel, hypercholesterolemia, hypertension, diabetes, biliary colic.
  • Having participated in a clinical study in the last 3 months.
  • Eating disorders.
  • Consumption of foods fortified with omega-3 fatty acids in the last 3 months.
  • Consumption of supplements of omega-3 fatty acids in the last 3 months.
  • Participant who have followed either a vegetarian diet for less than six months or an omnivorous diet including fish more than 2 times per week.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DHA supplement
Supplement rich in DHA form algae source
Dietary supplement: Dietary supplement, DHA or Placebo
Consumption of 2 capsules per day of the dietary supplement, DHA or Placebo
Placebo Comparator: Placebo
Placebo supplement
Dietary supplement: Dietary supplement, DHA or Placebo
Consumption of 2 capsules per day of the dietary supplement, DHA or Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum DHA
Time Frame: Baseline
Docosahexanoic acid concentration in serum
Baseline
Serum DHA
Time Frame: week 6
Docosahexanoic acid concentration in serum
week 6
Serum DHA
Time Frame: week 12
Docosahexanoic acid concentration in serum
week 12
Serum DHA
Time Frame: week 18
Docosahexanoic acid concentration in serum
week 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Council, Spain

Collaborators

Comunidad de Madrid

Investigators

  • Principal Investigator: M.Pilar Vaquero, Dr, CSIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2020

Primary Completion (Actual)

July 5, 2021

Study Completion (Actual)

July 5, 2021

Study Registration Dates

First Submitted

February 18, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IND2018/BIO-9554

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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