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

Higher Council for Scientific Research (CSIC)

Status: Completed

Conditions: Vegetarian Diet

Treatments: Dietary Supplement: Dietary supplement, DHA or Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04278482

IND2018/BIO-9554

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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102 participants in 2 patient groups, including a placebo group

DHA supplement

Active Comparator group

Description:

Supplement rich in DHA form algae source

Treatment:

Dietary Supplement: Dietary supplement, DHA or Placebo

Placebo

Placebo Comparator group

Description:

Placebo supplement

Treatment:

Dietary Supplement: Dietary supplement, DHA or Placebo