AgingMIA_ENCT05120791
Age Related Effects Consuming Phaeodactylum Tricornutum
A study testing microalgae phaeodactylum, From the Microalgae phaeodactylum the extracted beta-Glucan (especially chrysolaminarin) and A combination of the vegetable bouillon, the microalgae and the beta-Glucan in people with Aging and Well Aging, run by University of Hohenheim at 1 site in Germany.
Trial summary
Investigation of the microalgae Phaeodactylum as food with regard to the uptake of omega-3 fatty acids and effects on various blood parameters in relation to age. Bioavailability and excretion of nutrients and their effects on fatty acid status and inflammatory markers. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Well Aging
- What is being tested?
- microalgae phaeodactylum, From the Microalgae phaeodactylum the extracted beta-Glucan (especially chrysolaminarin) and A combination of the vegetable bouillon, the microalgae and the beta-Glucan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2022to Aug 2022
- 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥60 ≤90 years, weight ≥50 kg, generally healthy
- Signed informed consent form
- Willingness to follow the prescribed diet for the duration of the study
- No participation in any other clinical trial (current or within the last 30 days)
Who cannot join
- Taking intestinal therapeutics, antibiotics, immunosuppressants or similar. (if necessary, decision on a case-by-case basis)
- Pregnancy/breastfeeding
- Relevant violations of the dietary protocol
- Occurrence of relevant diseases (if necessary, individual case decision)
- Withdrawal of consent
- Placement in a clinic or similar facility due to official or court order
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Stephan C. Bischoff, Prof. Dr
Stuttgart, Baden-Wurttemberg
About this study
Official title: Health-promoting Effects of the Microalga Phaeodactylum Tricornutum - Bioavailability and Excretion of Nutrients in Relation to Age and Their Effects on Fatty Acid Status and Inflammatory Markers".
Investigation of the microalgae Phaeodactylum as food with regard to the uptake of omega-3 fatty acids and effects on various blood parameters in relation to age.
Bioavailability and excretion of nutrients and their effects on fatty acid status and inflammatory markers.
Read the detailed description
Due to a multifaceted redesign of all areas of life, older people face many nutritional challenges, such as cognitive change, sarcopenia and micronutrient deficiency. In addition to age-associated diseases, cognitive decline is usually a precursor to neurodegenerative processes, such as Alzheimer's disease. The full molecular mechanisms are still unknown, but classic aging mechanisms, such as oxidative stress and subclinical inflammation, play a role. Due to the changed life situation, there is a reduced need for energy, while the need for nutrients remains, which greatly increases the risk of malnutrition in old age. This results in an increasing prevalence of sarcopenia. The decrease in muscle mass and strength leads to functional limitations in the elderly and also promotes oxidative stress. This increases the need for antioxidant nutrients such as carotenoids and vitamins. Studies show that age-related chronic subclinical inflammation, such as occurs in the context of an omega-6 fatty acid (-FS) emphasized diet, plays a central role in the pathogenesis of age-associated diseases
Due to this, the microalgae PT could be a goud supplier of nutrients like omega-3 FS, especially eicosapentaenoic acid (EPA), which is otherwise found mainly in fatty fish, and Fucoxanthin, an antioxidant. The investigator study the change of omega-3, -6 and -9 FS in blood plasma, in erythrocytes, as well as the change of fucoxanthin and beta-carotene. The investigator measure blood parameters for safety and control the influence on the intestinal barrier.
- Conditions
- Aging, Well Aging
- Being tested
- Placebo vegetable bouillon, microalgae phaeodactylum, From the Microalgae phaeodactylum the extracted beta-Glucan (especially chrysolaminarin), A combination of the vegetable bouillon, the microalgae and the beta-Glucan
- Keywords
- Microalgae, omega-3 fatty acids, Micronutrients, carotinoids, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo vegetable bouillonDietary supplement
14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1,3g)
microalgae phaeodactylumDietary supplement
14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), 2.3g Microalgae Phaeodactylum
From the Microalgae phaeodactylum the extracted beta-Glucan (especially chrysolaminarin)Dietary supplement
14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), Beta-Glucan (1.8g)
A combination of the vegetable bouillon, the microalgae and the beta-GlucanDietary supplement
14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), 2.3g Microalgae, Beta-Glucan (1.8g)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1,3g) Receives: Dietary Supplement: Placebo vegetable bouillon |
| Microalgae phaeodactylum | Active comparator | 14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), 2.3g Microalgae Phaeodactylum Receives: Dietary Supplement: microalgae phaeodactylum |
| Beta-Glucan | Active comparator | 14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), Beta-Glucan (1.8g) Receives: Dietary Supplement: From the Microalgae phaeodactylum the extracted beta-Glucan (especially chrysolaminarin) |
| Combi Microalgae phaeodacytlum and Beta-Glucan | Active comparator | 14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), 2.3g Microalgae, Beta-Glucan (1.8g) Receives: Dietary Supplement: A combination of the vegetable bouillon, the microalgae and the beta-Glucan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in omega-6/omega-3 ratio (plasma level basis)
fatty acid chromatographic measurement
Measured: 14 days
Secondary outcomes (3)
Omega-3 fatty acid index
fatty acid chromatographic measurement in red blood cells
Measured: 14 days
Uptake of fucoxanthin and beta-carotene
chromatographic measurement in plasma
Measured: 14 days
Inflammation (CRP)
measurement in blood serum
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study startJul 2022 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4 arm parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
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
- NCT05120791
- Sponsor's protocol ID
- MIA_E
- Acronym
- MIA_E
- Status last verified
- Jul 2022
- First submitted
- 26 Oct 2021
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- 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 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-promoting Effects of the Microalga Phaeodactylum Tricornutum - Bioavailability and Excretion of Nutrients in Relation to Age and Their Effects on Fatty Acid Status and Inflammatory Markers".
- ClinicalTrials.gov ID
- NCT05120791
- Acronym / sponsor ID
- MIA_E / MIA_E
- Conditions
- Aging, Well Aging
- Keywords
- Microalgae, omega-3 fatty acids, Micronutrients, carotinoids, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 15 Nov 2021 (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.
Investigation of the microalgae Phaeodactylum as food with regard to the uptake of omega-3 fatty acids and effects on various blood parameters in relation to age.
Bioavailability and excretion of nutrients and their effects on fatty acid status and inflammatory markers.
Detailed description
Due to a multifaceted redesign of all areas of life, older people face many nutritional challenges, such as cognitive change, sarcopenia and micronutrient deficiency. In addition to age-associated diseases, cognitive decline is usually a precursor to neurodegenerative processes, such as Alzheimer's disease. The full molecular mechanisms are still unknown, but classic aging mechanisms, such as oxidative stress and subclinical inflammation, play a role. Due to the changed life situation, there is a reduced need for energy, while the need for nutrients remains, which greatly increases the risk of malnutrition in old age. This results in an increasing prevalence of sarcopenia. The decrease in muscle mass and strength leads to functional limitations in the elderly and also promotes oxidative stress. This increases the need for antioxidant nutrients such as carotenoids and vitamins. Studies show that age-related chronic subclinical inflammation, such as occurs in the context of an omega-6 fatty acid (-FS) emphasized diet, plays a central role in the pathogenesis of age-associated diseases
Due to this, the microalgae PT could be a goud supplier of nutrients like omega-3 FS, especially eicosapentaenoic acid (EPA), which is otherwise found mainly in fatty fish, and Fucoxanthin, an antioxidant. The investigator study the change of omega-3, -6 and -9 FS in blood plasma, in erythrocytes, as well as the change of fucoxanthin and beta-carotene. The investigator measure blood parameters for safety and control the influence on the intestinal barrier.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 4 arm parallel groups
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo vegetable bouillon14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1,3g) |
| Microalgae phaeodactylum | Active comparator | Dietary Supplement: microalgae phaeodactylum14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), 2.3g Microalgae Phaeodactylum |
| Beta-Glucan | Active comparator | Dietary Supplement: From the Microalgae phaeodactylum the extracted beta-Glucan (especially chrysolaminarin)14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), Beta-Glucan (1.8g) |
| Combi Microalgae phaeodacytlum and Beta-Glucan | Active comparator | Dietary Supplement: A combination of the vegetable bouillon, the microalgae and the beta-Glucan14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), 2.3g Microalgae, Beta-Glucan (1.8g) |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥60 ≤90 years, weight ≥50 kg, generally healthy
- Signed informed consent form
- Willingness to follow the prescribed diet for the duration of the study
- No participation in any other clinical trial (current or within the last 30 days)
Key exclusion criteria (6 listed)
- Taking intestinal therapeutics, antibiotics, immunosuppressants or similar. (if necessary, decision on a case-by-case basis)
- Pregnancy/breastfeeding
- Relevant violations of the dietary protocol
- Occurrence of relevant diseases (if necessary, individual case decision)
- Withdrawal 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 |
|---|---|---|
| Placebo vegetable bouillon14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1,3g) | Dietary supplement | Placebo |
| microalgae phaeodactylum14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), 2.3g Microalgae Phaeodactylum | Dietary supplement | Microalgae phaeodactylum |
| From the Microalgae phaeodactylum the extracted beta-Glucan (especially chrysolaminarin)14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), Beta-Glucan (1.8g) | Dietary supplement | Beta-Glucan |
| A combination of the vegetable bouillon, the microalgae and the beta-Glucan14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), 2.3g Microalgae, Beta-Glucan (1.8g) | Dietary supplement | Combi Microalgae phaeodacytlum and Beta-Glucan |
Primary outcome
Change in omega-6/omega-3 ratio (plasma level basis)
Time frame: 14 days
fatty acid chromatographic measurement
3 secondary outcomes
Omega-3 fatty acid index
Time frame: 14 days
Uptake of fucoxanthin and beta-carotene
Time frame: 14 days
Inflammation (CRP)
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microalgae phaeodactylum, From the Microalgae phaeodactylum the extracted beta-Glucan (especially chrysolaminarin) and A combination of the vegetable bouillon, the microalgae and the beta-Glucan in people with Aging and Well Aging, run by University of Hohenheim at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 6 Jul 2022. 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 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephan C Bischoff, Prof. Dr (0711 459 24101, bischoff.stephan@uni-hohenheim.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in omega-6/omega-3 ratio (plasma level basis) (time frame: 14 days). 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 6 Jul 2022.