Human Nutrition, Omega-3 Fatty Acids, MicroalgaeUniHoh-AlgenNCT04288544
"Health Promoting Effects of the Microalgae Phaeodactylum Tricornutum"
A study testing Microalgae, Omega-3-fatty acid capsule and sea fish in people with Human Nutrition, Omega-3 Fatty Acids, Microalgae and Micronutrients, run by University of Hohenheim at 2 sites in Germany.
Trial summary
The aim of the research project is to investigate the uptake of omega-3 fatty acids into the blood plasma through the consumption of the microalgae Phaeodactylum tricornutum (PT) in a human study. In an open, crossover study, the volunteers will receive a drink enriched with the microalgae P. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Nutrition, Omega-3 Fatty Acids, Microalgae, Micronutrients
- What is being tested?
- Microalgae, Omega-3-fatty acid capsule and sea fish
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesGermany
- Study dates
- 25 Feb 2020to 15 Sep 2020
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed declaration of consent
- Willingness to follow the prescribed diet for the duration of the study
- No participation in another clinical trial (current or within the last 30 days)
Who cannot join
- Taking intestinal therapeutics, antibiotics, immunosuppressive drugs or similar (if necessary, individual case decision)
- Pregnancy/nursing period
- Relevant violations of the food protocol
- Occurrence of relevant diseases (if necessary, individual case decision)
- Revocation of consent
- Accommodation in a clinic or similar institution due to official or court order
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
lena Stiefvatter
Stuttgart, 70599
University of Hohenheim
Stuttgart, 70599
About this study
Official title: Pilot Study "Health Promoting Effects of the Microalgae Phaeodactylum Tricornutum"
The aim of the research project is to investigate the uptake of omega-3 fatty acids into the blood plasma through the consumption of the microalgae Phaeodactylum tricornutum (PT) in a human study. In an open, crossover study, the volunteers will receive a drink enriched with the microalgae P. tricornutum or an omega-3 fatty acid preparation or (optionally) pollock for 14 days each. Since the microalgae P. tricornutum is rich in omega-3 fatty acids, the target parameter chosen is the uptake of omega-3 fatty acids in the blood plasma
Read the detailed description
A large number of diet-related diseases, such as obesity, are characterized by subclinical inflammation of the body. For this reason, anti-inflammatory foods such as omega-3 fatty acids, which are found in fish and nuts, are used. However, the disadvantage of fish as a resource is its limited availability. Therefore, it is of great interest to provide a resource-saving diet that still supplies us with all macro and micro nutrients. For this reason, microalgae have become the focus of science in recent years. Microalgae not only serve as a source of protein, but also contain a large number of nutrients that could have possible physiological and preventive effects in human nutrition. These include substances from the group of carotenoids and the various polyunsaturated FS found in microalgae.
The microalgae PT is rich in omega-3 FS eicosapentaenoic acid (EPA), which is otherwise found mainly in fatty fish, and could therefore be an alternative or vegetarian source of polyunsaturated fatty acids.
Previous work by U. Neumann has shown that the microalgae P. tricornutum could be used for human nutrition. No toxic effects could be observed in vivo and the bioavailability of fatty acids and proteins could also be successfully demonstrated. In vitro experiments also showed a more anti-inflammatory, anti-oxidative and anti-proliferative effect on human blood cells. For this reason, a health-promoting effect is also possible in human nutrition, but this must be proven in human studies.
- Being tested
- Microalgae, Omega-3-fatty acid capsule, sea fish
- Keywords
- eicosapentaenoic acid, Nutrition, micronutrients, anti-inflammatory foods, omega-3 fatty acids, microalgae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroalgaeDietary supplement
Open, monocentric intervention study in crossover design
Omega-3-fatty acid capsuleDietary supplement
Open, monocentric intervention study in crossover design
sea fishDietary supplement
Open, monocentric intervention study in crossover design
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention group | Active comparator | The patients get 1x 5,3g per day the microalgae Phaeodactylum tricornutumover for two weeks. Receives: Dietary Supplement: Omega-3-fatty acid capsule; Dietary Supplement: sea fish |
| Omega-3 capsules | Active comparator | The patients get one capsule per day of the Omega-3-fatty acid capsules for 2 weeks. Receives: Dietary Supplement: Microalgae; Dietary Supplement: sea fish |
| sea fish (facultative) | Experimental | as positive control, one portion of fish is eaten per week for 2 weeks after the Intervention of 8 weeks and 2 wash out (omega 3 must not be eaten). Receives: Dietary Supplement: Microalgae; Dietary Supplement: Omega-3-fatty acid capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of concentration of omega-3 fatty acids in blood plasma
concentration of fatty acids from plasma by direct transesterification and subsequent measurement on gas chromatography.
Measured: Study examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.
Secondary outcomes (1)
change of concentration of amino acids and carotenoids (fucoxanthin)
determination of amino acids from plasma by a gas chromatography determination of carotenoids from plasma by HPLC
Measured: Study examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start25 Feb 2020
- Primary completion12 Jun 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Nutrition, Omega-3 Fatty Acids, MicroalgaeStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan C. Bischoff, MD, Professor, University of Hohenheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288544
- Sponsor's protocol ID
- UHohenheim
- Acronym
- UniHoh-Algen
- Status last verified
- Oct 2021
- First submitted
- 21 Feb 2020
- Last updated
- 1 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study "Health Promoting Effects of the Microalgae Phaeodactylum Tricornutum"
- ClinicalTrials.gov ID
- NCT04288544
- Acronym / sponsor ID
- UniHoh-Algen / UHohenheim
- Keywords
- eicosapentaenoic acid, Nutrition, micronutrients, anti-inflammatory foods, omega-3 fatty acids, microalgae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 28 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.
The aim of the research project is to investigate the uptake of omega-3 fatty acids into the blood plasma through the consumption of the microalgae Phaeodactylum tricornutum (PT) in a human study. In an open, crossover study, the volunteers will receive a drink enriched with the microalgae P. tricornutum or an omega-3 fatty acid preparation or (optionally) pollock for 14 days each. Since the microalgae P. tricornutum is rich in omega-3 fatty acids, the target parameter chosen is the uptake of omega-3 fatty acids in the blood plasma
Detailed description
A large number of diet-related diseases, such as obesity, are characterized by subclinical inflammation of the body. For this reason, anti-inflammatory foods such as omega-3 fatty acids, which are found in fish and nuts, are used. However, the disadvantage of fish as a resource is its limited availability. Therefore, it is of great interest to provide a resource-saving diet that still supplies us with all macro and micro nutrients. For this reason, microalgae have become the focus of science in recent years. Microalgae not only serve as a source of protein, but also contain a large number of nutrients that could have possible physiological and preventive effects in human nutrition. These include substances from the group of carotenoids and the various polyunsaturated FS found in microalgae.
The microalgae PT is rich in omega-3 FS eicosapentaenoic acid (EPA), which is otherwise found mainly in fatty fish, and could therefore be an alternative or vegetarian source of polyunsaturated fatty acids.
Previous work by U. Neumann has shown that the microalgae P. tricornutum could be used for human nutrition. No toxic effects could be observed in vivo and the bioavailability of fatty acids and proteins could also be successfully demonstrated. In vitro experiments also showed a more anti-inflammatory, anti-oxidative and anti-proliferative effect on human blood cells. For this reason, a health-promoting effect is also possible in human nutrition, but this must be proven in human studies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention group | Active comparator | Dietary Supplement: Omega-3-fatty acid capsule, Dietary Supplement: sea fishThe patients get 1x 5,3g per day the microalgae Phaeodactylum tricornutumover for two weeks. |
| Omega-3 capsules | Active comparator | Dietary Supplement: Microalgae, Dietary Supplement: sea fishThe patients get one capsule per day of the Omega-3-fatty acid capsules for 2 weeks. |
| sea fish (facultative) | Experimental | Dietary Supplement: Microalgae, Dietary Supplement: Omega-3-fatty acid capsuleas positive control, one portion of fish is eaten per week for 2 weeks after the Intervention of 8 weeks and 2 wash out (omega 3 must not be eaten). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Signed declaration of consent
- Willingness to follow the prescribed diet for the duration of the study
- No participation in another clinical trial (current or within the last 30 days)
Key exclusion criteria (6 listed)
- Taking intestinal therapeutics, antibiotics, immunosuppressive drugs or similar (if necessary, individual case decision)
- Pregnancy/nursing period
- Relevant violations of the food protocol
- Occurrence of relevant diseases (if necessary, individual case decision)
- Revocation of consent
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 |
|---|---|---|
| MicroalgaeOpen, monocentric intervention study in crossover design | Dietary supplement | Omega-3 capsules, sea fish (facultative) |
| Omega-3-fatty acid capsuleOpen, monocentric intervention study in crossover design | Dietary supplement | Experimental: Intervention group, sea fish (facultative) |
| sea fishOpen, monocentric intervention study in crossover design | Dietary supplement | Experimental: Intervention group, Omega-3 capsules |
Primary outcome
change of concentration of omega-3 fatty acids in blood plasma
Time frame: Study examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.
concentration of fatty acids from plasma by direct transesterification and subsequent measurement on gas chromatography.
1 secondary outcome
change of concentration of amino acids and carotenoids (fucoxanthin)
Time frame: Study examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.
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 1 Nov 2021.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microalgae, Omega-3-fatty acid capsule and sea fish in people with Human Nutrition, Omega-3 Fatty Acids, Microalgae and Micronutrients, run by University of Hohenheim at 2 sites in Germany.
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 3 inclusion and 6 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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. 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?
change of concentration of omega-3 fatty acids in blood plasma (time frame: Study examinations are before intervention, after 2,3,4,6,7,8, 10,11 and 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2021.