Age Related Effects Consuming Phaeodactylum Tricornutum

Aging Clinical Trial

— MIA_E  

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".

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05120791
• Other study ID #: MIA_E
• Status: Recruiting
• Phase: N/A
• Start date: July 2022
• Est. completion date: August 2022

Study information

• Verified date: July 2022
• Source: University of Hohenheim
• Contact: Stephan C Bischoff, Prof. Dr
• Phone: 0711 459 24101
• Email: bischoff.stephan[@]uni-hohenheim.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Well Aging

Intervention

Dietary Supplement:
• Placebo vegetable bouillon
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
• 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)
• 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)

Locations

Country	Name	City	State
Germany	Stephan C. Bischoff, Prof. Dr	Stuttgart	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Hohenheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Markers for oxidative stress	lipid hydroperoxides)	14 days
Other	Albumin	Measurement in serum	14 days
Other	weight	in kilograms	14 days
Other	FFQ- Food frequence questionnaire	Food questionnaire about the general eating of the last 4 weeks	4 weeks
Primary	Change in omega-6/omega-3 ratio (plasma level basis)	fatty acid chromatographic measurement	14 days
Secondary	Omega-3 fatty acid index	fatty acid chromatographic measurement in red blood cells	14 days
Secondary	Uptake of fucoxanthin and beta-carotene	chromatographic measurement in plasma	14 days
Secondary	Inflammation (CRP)	measurement in blood serum	14 days