Age Related Effects Consuming Phaeodactylum Tricornutum

NCT ID: NCT05120791

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2022-08-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo vegetable bouillon

Intervention Type: DIETARY_SUPPLEMENT

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

Microalgae phaeodactylum

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

Group Type: ACTIVE_COMPARATOR

microalgae phaeodactylum

Intervention Type: DIETARY_SUPPLEMENT

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

Beta-Glucan

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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)

Combi Microalgae phaeodacytlum and Beta-Glucan

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)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DIETARY_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)

Interventions

Placebo vegetable bouillon

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

Intervention Type: DIETARY_SUPPLEMENT

microalgae phaeodactylum

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

Intervention Type: 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)

Intervention Type: DIETARY_SUPPLEMENT

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

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)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Hohenheim

OTHER

Sponsor Role: lead

Responsible Party

Stephan C. Bischoff, MD, Professor

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stephan C. Bischoff, Prof. Dr

Stuttgart, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Stephan C Bischoff, Prof. Dr

Role: CONTACT

bischoff.stephan@uni-hohenheim.de

0711 459 24101

Lena Stiefvatter, M.SC

Role: CONTACT

lena.stiefvatter@uni-hohenheim.de

071145924881

Other Identifiers

MIA_E

Identifier Type: -

Identifier Source: org_study_id