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OpenTrials
Completed

NCT Number: NCT04278482

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

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.

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Key information

Conditions

Vegetarian Diet

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M.Pilar Vaquero

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary supplement, DHA or Placebo

Dietary Supplement

Consumption of 2 capsules per day of the dietary supplement, DHA or Placebo

Primary outcomes

  1. Serum DHA

    Time frame: Baseline

    Docosahexanoic acid concentration in serum

  2. Serum DHA

    Time frame: week 6

    Docosahexanoic acid concentration in serum

  3. Serum DHA

    Time frame: week 12

    Docosahexanoic acid concentration in serum

  4. Serum DHA

    Time frame: week 18

    Docosahexanoic acid concentration in serum

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Collaborators

  • Comunidad de Madrid

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 20, 2020
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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