Age Related Effects Consuming Phaeodactylum Tricornutum

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Aging, Well Aging

Intervention / Treatment
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* Dietary Supplement: Placebo vegetable bouillon
* Dietary Supplement: microalgae phaeodactylum
* Dietary Supplement: From the Microalgae phaeodactylum the extracted beta-Glucan (especially chrysolaminarin)
* Dietary Supplement: A combination of the vegetable bouillon, the microalgae and the beta-Glucan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 4 arm parallel groups
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1,3g) | Dietary Supplement: Placebo vegetable bouillon<br>* 14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1,3g)<br>|
| Active Comparator: Microalgae phaeodactylum<br>14 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<br>* 14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), 2.3g Microalgae Phaeodactylum<br>|
| Active Comparator: Beta-Glucan<br>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: From the Microalgae phaeodactylum the extracted beta-Glucan (especially chrysolaminarin)<br>* 14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), Beta-Glucan (1.8g)<br>|
| Active Comparator: Combi Microalgae phaeodacytlum and Beta-Glucan<br>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) | Dietary Supplement: A combination of the vegetable bouillon, the microalgae and the beta-Glucan<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in omega-6/omega-3 ratio (plasma level basis) | fatty acid chromatographic measurement | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Omega-3 fatty acid index | fatty acid chromatographic measurement in red blood cells | 14 days | 
| Uptake of fucoxanthin and beta-carotene | chromatographic measurement in plasma | 14 days | 
| Inflammation (CRP) | measurement in blood serum | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microalgae, omega-3 fatty acids, Micronutrients, carotinoids, Inflammation