Clinical trial NCT05120791: Age Related Effects Consuming Phaeodactylum Tricornutum
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".
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Well Aging
Keywords: Microalgae
omega-3 fatty acids
Micronutrients
carotinoids
Inflammation
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 arm parallel groups
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in omega-6/omega-3 ratio (plasma level basis)
timeFrame: 14 days
Secondary outcomes:
measure: Omega-3 fatty acid index
timeFrame: 14 days
measure: Uptake of fucoxanthin and beta-carotene
timeFrame: 14 days
measure: Inflammation (CRP)
timeFrame: 14 days
Other outcomes:
measure: Markers for oxidative stress
timeFrame: 14 days
measure: Albumin
timeFrame: 14 days
measure: weight
timeFrame: 14 days
measure: FFQ- Food frequence questionnaire
timeFrame: 4 weeks
Locations:
city: Stuttgart
country: Germany
facility: Stephan C. Bischoff, Prof. Dr
state: Baden-Württemberg
Study officials:
References: