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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05120791
Other study ID # MIA_E
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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