"Diseño y Validación en Humanos de un Nuevo Complemento Alimenticio Rico en Ácido Docosahexaenoico (DHA) Procedente de Algas"
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- National Research Council, Spain
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Serum DHA
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult (age ≥18 and ≤45 years).
- •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.
Outcomes
Primary Outcomes
Serum DHA
Time Frame: week 18
Docosahexanoic acid concentration in serum
Secondary Outcomes
No secondary outcomes reported
Investigators
M Pilar Vaquero
Dr
National Research Council, Spain