NCT04278482

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

March 10, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2021

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

February 18, 2020

Last Update Submit

January 13, 2023

Conditions

Vegetarian Diet

Keywords

Vegetarian dietsPlant-based dietsVegetariansVegansdocosahexaenoic acidDHAomega-3 fatty acidsalgaesupplementation

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

DHA supplement

ACTIVE COMPARATOR

Supplement rich in DHA form algae source

Dietary Supplement: Dietary supplement, DHA or Placebo

Placebo

PLACEBO COMPARATOR

Placebo supplement

Dietary Supplement: Dietary supplement, DHA or Placebo

Interventions

Dietary supplement, DHA or PlaceboDIETARY_SUPPLEMENT

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

DHA supplementPlacebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M.Pilar Vaquero

Madrid, 28040, Spain

Location

Related Publications (1)

  • 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.

    PMID: 36418565RESULT

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • M.Pilar Vaquero, Dr

    CSIC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 20, 2020

Study Start

March 10, 2020

Primary Completion

July 5, 2021

Study Completion

July 5, 2021

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)