Age Related Effects Consuming Phaeodactylum Tricornutum

Not Applicable

• Conditions: Aging; Well Aging
• Interventions: Dietary Supplement: microalgae phaeodactylum; Dietary Supplement: Placebo vegetable bouillon; 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)

• Registration Number: NCT05120791
• Lead Sponsor: University of Hohenheim

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.

Study Timeline

• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-15
• Status Verified: 2022-07
• Study Start: 2022-07
• Primary Completion: 2022-07
• Last Update Submitted: 2022-07-04
• Last Update Posted: 2022-07-06
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microalgae phaeodactylum	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
Placebo	Placebo vegetable bouillon	14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1,3g)
Combi Microalgae phaeodacytlum and Beta-Glucan	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)
Beta-Glucan	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)

Primary Outcome Measures

Name	Time	Method
Change in omega-6/omega-3 ratio (plasma level basis)	14 days	fatty acid chromatographic measurement

Secondary Outcome Measures

Name	Time	Method
Inflammation (CRP)	14 days	measurement in blood serum
Omega-3 fatty acid index	14 days	fatty acid chromatographic measurement in red blood cells
Uptake of fucoxanthin and beta-carotene	14 days	chromatographic measurement in plasma

Trial Locations

Locations (1)

Stephan C. Bischoff, Prof. Dr; 🇩🇪 Stuttgart, Baden-Württemberg, Germany