Clinical trial NCT04567823: Nutrient Bioavailability From Microalgae
Official title: Human Intervention Study for Validating Nutrient Bioavailability From Microalgae
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrient Deficiency
Keywords: microalgae
omega-3 fatty acids
vitamins
minerals
trace elements
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2020-09-29
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel design
Primary purpose: PREVENTION

Brief summary: The intervention study is designed to evaluate nutrient bioavailability and physiological impact of two selected microalgae species of interest in a randomized study in humans. The controlled study in parallel design will be conducted with healthy males and females between 20 and 35 years.

Detailed description: The microalgae are selected depending on their contents of long-chain omega-3 fatty acids, e.g. eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), high-quality protein (focus: essential amino acids), dietary fibers but also vitamin D pre-cursors and further vitamins, minerals and trace elements.The nutrient bioavailability is evaluated in a controlled, randomized, double-blind study in parallel design. The intervention products (smoothie enriched with Chlorella pyrenoidosa, Nannochloropsis salina) are consumed daily over 14 days. In addition, the background diet is standardised by provision of defined menu plans ensuring an optimal energy and nutrient intake. The control group I receive no intervention products and no menu plans and control group II receive a smoothie without microalage and defined menu plans.

A sup-group of five participants per group consume a test meal after the fasting blood sampling on the first study day. This is followed by a postprandial blood sampling after 30, 60, 90, 120 and 180 minutes.

The NovAL study is conducted to evaluate the bioavailability of nutrients such as omega-3 LC-PUFA, vitamin D, vitamin B12, further vitamins, amino acids, minerals, and trace elements from the selected microalgae species. Therefore, the concentration of these valuable nutrients and relevant markers of their status in humans (e.g. vitamin B12 status: holo-transcobalamin, methylmalonic acid, homocysteine; iron status: ferritin, transferrin, transferrin saturation) are analysed in the human biofluids (serum/plasma, erythrocytes, 24 h urine) before and after defined consumption of the selected microalgae species over 14 days. Besides the comprehensive analysis of the nutrient status in humans, cardiovascular risk factors and risk factors for diabetes mellitus type II are analysed. Thus, the NovAL study allows the assessment of i) the nutrient bioavailability from the selected microalgae species but also ii) their contribution on nutrient supply and prevention of non-communicable diseases such as cardiovascular diseases or diabetes mellitus type.

Eligibility criteria: Inclusion Criteria:

* females and males
* BMI \< 30 kg/m2
* subjects must be able and willing to give written informed consent, and to comply with study procedures
* participants following a traditional Western diet composed of dairy products, sausage, meat, fast foods, chocolate and snacks, cereals, vegetables, and fruits (PAL: 1.6)
* precondition: Stable eating habits of at least one years before enrolment
* subjects must have adequate fluency in the German language to complete the questionnaires and understand the nutritional recommendations

Exclusion Criteria:

* subjects with any acute or chronic disease (CVD, tumor, infection, other), gastrointestinal diseases, diabetes mellitus (type I and II), chronic renal disease, diseases of the parathyroid, diseases necessitating regular phlebotomies other chronic diseases which could affect the results of the present study
* use of prescription medicine which could affect results of the study, including systemic glucocorticoids
* intake of lipid-lowering drugs, diabetes medication, hormone replacement therapy
* estimated glomerular filtration (eGFR) rate \< 60 ml/min
* weight loss (≤ 3 kg) or weight gain (≥ 3 kg) during the last three months before study begin
* pregnancy or lactation
* transfusion of blood in the last three months before blood sample taking
* use of dietary supplements incl. multivitamins, fish oil capsules, minerals, and trace elements (three months before and during the entire study period)
* vegetarians, vegans, food allergies
* dependency on alcohol or drugs
* elite athletes (\>10 hours of strenuous physical activity per week)
* simultaneous participation in other clinical studies
* inability (physically or psychologically) to comply with the procedures required by the protocol

Primary outcomes:
measure: EPA concentration in plasma lipids
timeFrame: change from baseline after 2 weeks
Secondary outcomes:
measure: blood lipids
timeFrame: change from baseline after 2 weeks
measure: anthropometric data
timeFrame: change from baseline after 2 weeks
measure: body mass index
timeFrame: change from baseline after 2 weeks
measure: blood pressure
timeFrame: change from baseline after 2 weeks
measure: inflammation marker (blood)
timeFrame: change from baseline after 2 weeks
measure: homocysteine
timeFrame: change from baseline after 2 weeks
measure: holotranscobalamine
timeFrame: change from baseline after 2 weeks
measure: glucose (fasting)
timeFrame: change from baseline after 2 weeks
measure: insulin (fasting)
timeFrame: change from baseline after 2 weeks
measure: hemoglobin A1c (fasting)
timeFrame: change from baseline after 2 weeks
measure: malodialdehyde modified LDL cholesterol
timeFrame: change from baseline after 2 weeks
measure: fatty acid distribution in plasma lipids
timeFrame: change from baseline after 2 weeks
measure: aspartate transaminase
timeFrame: change from baseline after 2 weeks
measure: alanine transaminase
timeFrame: change from baseline after 2 weeks
measure: gamma-glutamyltransferase
timeFrame: change from baseline after 2 weeks
measure: lactate dehydrogenase
timeFrame: change from baseline after 2 weeks
measure: cholinesterase
timeFrame: change from baseline after 2 weeks
measure: kalium
timeFrame: change from baseline after 2 weeks
measure: calcium
timeFrame: change from baseline after 2 weeks
measure: transferrin
timeFrame: change from baseline after 2 weeks
measure: ferritin
timeFrame: change from baseline after 2 weeks
measure: iron
timeFrame: change from baseline after 2 weeks
measure: vitamin A
timeFrame: change from baseline after 2 weeks
measure: vitamin D
timeFrame: change from baseline after 2 weeks
measure: vitamin E
timeFrame: change from baseline after 2 weeks
measure: vitamin B1
timeFrame: change from baseline after 2 weeks
measure: vitamin B6
timeFrame: change from baseline after 2 weeks
measure: vitamin B12
timeFrame: change from baseline after 2 weeks
measure: folic acid
timeFrame: change from baseline after 2 weeks
measure: vitamin B2
timeFrame: change from baseline after 2 weeks
measure: vitamin C
timeFrame: change from baseline after 2 weeks
measure: vitamin H
timeFrame: change from baseline after 2 weeks
measure: iodine (24 h urine)
timeFrame: change from baseline after 2 weeks
measure: selenium (24 h urine)
timeFrame: change from baseline after 2 weeks
measure: copper (24 h urine)
timeFrame: change from baseline after 2 weeks
measure: zinc (24 h urine)
timeFrame: change from baseline after 2 weeks
measure: manganese (24 h urine)
timeFrame: change from baseline after 2 weeks
measure: natrium (24 h urine)
timeFrame: change from baseline after 2 weeks
measure: magnesium (24 h urine)
timeFrame: change from baseline after 2 weeks
measure: creatinine (24 h urine)
timeFrame: change from baseline after 2 weeks
measure: albumine (24 h urine)
timeFrame: change from baseline after 2 weeks
measure: uric acid (24 h urine)
timeFrame: change from baseline after 2 weeks
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich Schiller University
state: Thuringia
Study officials:
References: