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

Study Overview
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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.

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

Conditions
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Vegetarian Diet

Intervention / Treatment
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* Dietary Supplement: Dietary supplement, DHA or Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DHA supplement<br>Supplement rich in DHA form algae source | Dietary Supplement: Dietary supplement, DHA or Placebo<br>* Consumption of 2 capsules per day of the dietary supplement, DHA or Placebo<br>|
| Placebo Comparator: Placebo<br>Placebo supplement | Dietary Supplement: Dietary supplement, DHA or Placebo<br>* Consumption of 2 capsules per day of the dietary supplement, DHA or Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum DHA | Docosahexanoic acid concentration in serum | Baseline | 
| Serum DHA | Docosahexanoic acid concentration in serum | week 6 | 
| Serum DHA | Docosahexanoic acid concentration in serum | week 12 | 
| Serum DHA | Docosahexanoic acid concentration in serum | week 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vegetarian diets, Plant-based diets, Vegetarians, Vegans, docosahexaenoic acid, DHA, omega-3 fatty acids, algae, supplementation