Clinical trial NCT04278482: Effects of the Consumption of a Supplement Rich in Docosahexaenoic Acid (DHA) From Algae
Official title: "Diseño y Validación en Humanos de un Nuevo Complemento Alimenticio Rico en Ácido Docosahexaenoico (DHA) Procedente de Algas"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vegetarian Diet
Keywords: Vegetarian diets
Plant-based diets
Vegetarians
Vegans
docosahexaenoic acid
DHA
omega-3 fatty acids
algae
supplementation
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
Collaborators: name: Comunidad de Madrid
First posted: 2020-02-20
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Serum DHA
timeFrame: Baseline
measure: Serum DHA
timeFrame: week 6
measure: Serum DHA
timeFrame: week 12
measure: Serum DHA
timeFrame: week 18
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: M.Pilar Vaquero
Study officials:
affiliation: CSIC
name: M.Pilar Vaquero, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 2023 Jun;62(4):1691-1705. doi: 10.1007/s00394-022-03050-3. Epub 2022 Nov 23.