NCT04567823

Nutrient Bioavailability From Microalgae

Human Intervention Study for Validating Nutrient Bioavailability From Microalgae

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Jena · Academic / Other
• Sex: All
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nutrient Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Smoothie with microalgae	Smoothie with microalgae I: Chlorella pyrenoidosa, Smoothie with microalgae II: Nannochloropsis salina, Smoothie without microalgae

Timeline

• Start date: 2020-11-09
• Primary completion: 2020-12-12
• Completion: 2020-12-31
• First posted: 2020-09-29
• Last updated: 2021-01-13

Locations

1 site across 1 country: Germany