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

Vegetarian Diet Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04278482
• Other study ID #: IND2018/BIO-9554
• Status: Completed
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: July 5, 2021

Study information

• Verified date: January 2023
• Source: National Research Council, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 5, 2021
• Est. primary completion date: July 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vegetarian Diet

Intervention

Dietary Supplement:
• Dietary supplement, DHA or Placebo
Consumption of 2 capsules per day of the dietary supplement, DHA or Placebo

Locations

Country	Name	City	State
Spain	M.Pilar Vaquero	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
National Research Council, Spain	Comunidad de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Garcia-Maldonado E, Alcorta A, Zapatera B, Vaquero MP. Changes in fatty acid levels after consumption of a novel docosahexaenoic supplement from algae: a crossover randomized controlled trial in omnivorous, lacto-ovo vegetarians and vegans. Eur J Nutr. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum DHA	Docosahexanoic acid concentration in serum	Baseline
Primary	Serum DHA	Docosahexanoic acid concentration in serum	week 6
Primary	Serum DHA	Docosahexanoic acid concentration in serum	week 12
Primary	Serum DHA	Docosahexanoic acid concentration in serum	week 18