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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-10

Study Completion Date

2021-07-05

Brief Summary

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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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Detailed Description

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Conditions

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Vegetarian Diet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DHA supplement

Supplement rich in DHA form algae source

Group Type ACTIVE_COMPARATOR

Dietary supplement, DHA or Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Placebo supplement

Group Type PLACEBO_COMPARATOR

Dietary supplement, DHA or Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Dietary supplement, DHA or Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes