Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04567823
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2020-09-15
Brief Title:
Nutrient Bioavailability From Microalgae
Sponsor:
University of Jena
Organization:
University of Jena
Study Overview
Official Title:
Human Intervention Study for Validating Nutrient Bioavailability From Microalgae
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NovAL
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 eg 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 elementsThe 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 eg vitamin B12 status holo-transcobalamin methylmalonic acid homocysteine iron status ferritin transferrin transferrin saturation are analysed in the human biofluids serumplasma 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
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 eg vitamin B12 status holo-transcobalamin methylmalonic acid homocysteine iron status ferritin transferrin transferrin saturation are analysed in the human biofluids serumplasma 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None