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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04278482
Enrollment
102
Registered
2020-02-20
Start date
2020-03-10
Completion date
2021-07-05
Last updated
2023-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vegetarian Diet

Keywords

Vegetarian diets, Plant-based diets, Vegetarians, Vegans, docosahexaenoic acid, DHA, omega-3 fatty acids, algae, supplementation

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.

Interventions

DIETARY_SUPPLEMENTDietary supplement, DHA or Placebo

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

Sponsors

Comunidad de Madrid
CollaboratorOTHER
National Research Council, Spain
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Serum DHABaselineDocosahexanoic acid concentration in serum

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026