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

Not Applicable

Completed

• Conditions: Vegetarian Diet
• Interventions: Dietary Supplement: Dietary supplement, DHA or Placebo

• Registration Number: NCT04278482
• Lead Sponsor: National Research Council, Spain

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Study Start: 2020-03-10
• Primary Completion: 2021-07-05
• Study Completion: 2021-07-05
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Dietary supplement, DHA or Placebo	Placebo supplement
DHA supplement	Dietary supplement, DHA or Placebo	Supplement rich in DHA form algae source

Primary Outcome Measures

Name	Time	Method
Serum DHA	week 18	Docosahexanoic acid concentration in serum

Trial Locations

Locations (1)

M.Pilar Vaquero; 🇪🇸 Madrid, Spain