Age Related Effects Consuming Phaeodactylum Tricornutum (MIA_E)

University of Hohenheim

Status: Enrolling

Conditions: Aging; Well Aging

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05120791

MIA_E

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 65 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1,3g)

Treatment:

Dietary Supplement: Placebo vegetable bouillon

Microalgae phaeodactylum

Active Comparator group

Description:

14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), 2.3g Microalgae Phaeodactylum

Treatment:

Dietary Supplement: microalgae phaeodactylum

Beta-Glucan

Active Comparator group

Description:

14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1.3g), Beta-Glucan (1.8g)

Treatment:

Dietary Supplement: From the Microalgae phaeodactylum the extracted beta-Glucan (especially chrysolaminarin)

Combi Microalgae phaeodacytlum and Beta-Glucan

Active Comparator group

Description:

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)

Treatment:

Dietary Supplement: A combination of the vegetable bouillon, the microalgae and the beta-Glucan