Vegetarian DietNCT04278482
Effects of the Consumption of a Supplement Rich in Docosahexaenoic Acid (DHA) From Algae
A study of Vegetarian Diet, run by National Research Council, Spain at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vegetarian Diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteSpain
- Study dates
- 10 Mar 2020to 5 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: "Diseño y Validación en Humanos de un Nuevo Complemento Alimenticio Rico en Ácido Docosahexaenoico (DHA) Procedente de Algas"
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.
- Conditions
- Vegetarian Diet
- Being tested
- Dietary supplement, DHA or Placebo
- Keywords
- Vegetarian diets, Plant-based diets, Vegetarians, Vegans, docosahexaenoic acid, DHA, omega-3 fatty acids, algae, supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement, DHA or PlaceboDietary supplement
Consumption of 2 capsules per day of the dietary supplement, DHA or Placebo
| Study group | Role | What they receive |
|---|---|---|
| DHA supplement | Active comparator | Supplement rich in DHA form algae source Receives: Dietary Supplement: Dietary supplement, DHA or Placebo |
| Placebo | Placebo comparator | Placebo supplement Receives: Dietary Supplement: Dietary supplement, DHA or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum DHA
Docosahexanoic acid concentration in serum
Measured: Baseline
Serum DHA
Docosahexanoic acid concentration in serum
Measured: week 6
Serum DHA
Docosahexanoic acid concentration in serum
Measured: week 12
Serum DHA
Docosahexanoic acid concentration in serum
Measured: week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start10 Mar 2020
- Primary completion5 Jul 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vegetarian DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Collaborators
- Comunidad de Madrid
- Responsible party
- Principal investigator, M Pilar Vaquero, National Research Council, Spain
- Investigators
- M.Pilar Vaquero, Dr, Principal investigator, CSIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278482
- Sponsor's protocol ID
- IND2018/BIO-9554
- Status last verified
- Jan 2023
- First submitted
- 18 Feb 2020
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36418565
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Diseño y Validación en Humanos de un Nuevo Complemento Alimenticio Rico en Ácido Docosahexaenoico (DHA) Procedente de Algas"
- ClinicalTrials.gov ID
- NCT04278482
- Acronym / sponsor ID
- IND2018/BIO-9554
- Conditions
- Vegetarian Diet
- Keywords
- Vegetarian diets, Plant-based diets, Vegetarians, Vegans, docosahexaenoic acid, DHA, omega-3 fatty acids, algae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Collaborators
- Comunidad de Madrid
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA supplement | Active comparator | Dietary Supplement: Dietary supplement, DHA or PlaceboSupplement rich in DHA form algae source |
| Placebo | Placebo comparator | Dietary Supplement: Dietary supplement, DHA or PlaceboPlacebo supplement |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary supplement, DHA or PlaceboConsumption of 2 capsules per day of the dietary supplement, DHA or Placebo | Dietary supplement | DHA supplement, Placebo |
Primary outcome
Serum DHA
Time frame: Baseline
Docosahexanoic acid concentration in serum
Serum DHA
Time frame: week 6
Docosahexanoic acid concentration in serum
Serum DHA
Time frame: week 12
Docosahexanoic acid concentration in serum
Serum DHA
Time frame: week 18
Docosahexanoic acid concentration in serum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Results publication: PubMed 36418565Garcia-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M.Pilar Vaquero, Dr principal investigator
CSIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Vegetarian Diet, run by National Research Council, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum DHA (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04278482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.