Age Related Effects Consuming Phaeodactylum Tricornutum (MIA_E)

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".

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.

Study Overview

• Status: Recruiting
• Conditions: Aging; Well Aging
• Intervention / Treatment: Dietary supplement: Placebo vegetable bouillon; Dietary supplement: microalgae phaeodactylum; Dietary supplement: From the Microalgae phaeodactylum the extracted beta-Glucan (especially chrysolaminarin); Dietary supplement: A combination of the vegetable bouillon, the microalgae and the beta-Glucan

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephan C Bischoff, Prof. Dr; Phone Number: 0711 459 24101; Email: bischoff.stephan@uni-hohenheim.de
• Study Contact Backup: Name: Lena Stiefvatter, M.SC; Phone Number: 071145924881; Email: lena.stiefvatter@uni-hohenheim.de

Study Locations

• Germany
  • Baden-Württemberg
    • Stuttgart, Baden-Württemberg, Germany
      • Recruiting
      • Stephan C. Bischoff, Prof. Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1,3g)	Dietary supplement: Placebo vegetable bouillon; 14 days wahs-out: no fish eating 14 days: no fish eating, the participants eat vegetable bouillon (1,3g)
Active Comparator: 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	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
Active Comparator: 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)	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)
Active Comparator: 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)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in omega-6/omega-3 ratio (plasma level basis)	fatty acid chromatographic measurement	14 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Markers for oxidative stress	lipid hydroperoxides)	14 days
Albumin	Measurement in serum	14 days
weight	in kilograms	14 days
FFQ- Food frequence questionnaire	Food questionnaire about the general eating of the last 4 weeks	4 weeks

Collaborators and Investigators

• Sponsor: University of Hohenheim

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Inflammation; Micronutrients; omega-3 fatty acids; Microalgae; carotinoids
• Other Study ID Numbers: MIA_E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No