Nutrient Bioavailability From Microalgae (NovAL)

• ClinicalTrials.gov Identifier: NCT04567823
• Recruitment Status: Completed
• First Posted: September 29, 2020
• Last Update Posted: January 13, 2021
• Sponsor: University of Jena
• Collaborator: German Federal Ministry of Education and Research
• Information provided by (Responsible Party): Christine Dawczynski,PhD, University of Jena

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Nutrient Deficiency	Dietary Supplement: Smoothie with microalgae	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: parallel design
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: It is not visible whether the smoothie is fortified with microalgae or not.
• Primary Purpose: Prevention
• Official Title: Human Intervention Study for Validating Nutrient Bioavailability From Microalgae
• Actual Study Start Date: November 9, 2020
• Actual Primary Completion Date: December 12, 2020
• Actual Study Completion Date: December 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Microalgae I; Smoothie (enriched with Chlorella pyrenoidosa) and standardised background diet (defined menu plans)	Dietary Supplement: Smoothie with microalgae; Smoothie with microalgae I: Chlorella pyrenoidosa, Smoothie with microalgae II: Nannochloropsis salina, Smoothie without microalgae
Experimental: Microalgae II; Smoothie (enriched with Nannochloropsis salina) and standardised background diet (defined menu plans)	Dietary Supplement: Smoothie with microalgae; Smoothie with microalgae I: Chlorella pyrenoidosa, Smoothie with microalgae II: Nannochloropsis salina, Smoothie without microalgae
Placebo Comparator: Smoothie; Smoothie (without microalgae) and standardised background diet (defined menu plans)	Dietary Supplement: Smoothie with microalgae; Smoothie with microalgae I: Chlorella pyrenoidosa, Smoothie with microalgae II: Nannochloropsis salina, Smoothie without microalgae
No Intervention: Control; no intervention (no smoothie, no menu plans)

Outcome Measures

Primary Outcome Measures :

1. EPA concentration in plasma lipids [ Time Frame: change from baseline after 2 weeks ]
   concentration of eicosapentaenoic acid (EPA) in % fatty acid methyl esthers (FAME) in plasma lipids

Secondary Outcome Measures :

1. blood lipids [ Time Frame: change from baseline after 2 weeks ]
   total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides in mmol/l
2. anthropometric data [ Time Frame: change from baseline after 2 weeks ]
   body water, body fat, lean body mass, extracellular mass (ECM), body cell mass (BCM) in %
3. body mass index [ Time Frame: change from baseline after 2 weeks ]
   body mass index (kg/m2)
4. blood pressure [ Time Frame: change from baseline after 2 weeks ]
   systolic blood pressure (mm Hg) diastolic blood pressure (mmHg)
5. inflammation marker (blood) [ Time Frame: change from baseline after 2 weeks ]
   high-sensitive c-reactive protein (mg/dl)
6. homocysteine [ Time Frame: change from baseline after 2 weeks ]
   homocysteine (µmol/l)
7. holotranscobalamine [ Time Frame: change from baseline after 2 weeks ]
   holotranscobalamine (pmol/l)
8. glucose (fasting) [ Time Frame: change from baseline after 2 weeks ]
   glucose (fasting) (mmol/l)
9. insulin (fasting) [ Time Frame: change from baseline after 2 weeks ]
   insulin (fasting) (mU/l)
10. hemoglobin A1c (fasting) [ Time Frame: change from baseline after 2 weeks ]
    hemoglobin A1c (fasting) (%)
11. malodialdehyde modified LDL cholesterol [ Time Frame: change from baseline after 2 weeks ]
    malodialdehyde modified LDL cholesterol (U/l)
12. fatty acid distribution in plasma lipids [ Time Frame: change from baseline after 2 weeks ]
    fatty acid distribution in plasma lipids in % FAME
13. aspartate transaminase [ Time Frame: change from baseline after 2 weeks ]
    aspartate transaminase (ASAT) in µmol/l*s
14. alanine transaminase [ Time Frame: change from baseline after 2 weeks ]
    alanine transaminase (ALAT) in µmol/l*s
15. gamma-glutamyltransferase [ Time Frame: change from baseline after 2 weeks ]
    gamma-glutamyltransferase (gGT) in µmol/l*s
16. lactate dehydrogenase [ Time Frame: change from baseline after 2 weeks ]
    lactate dehydrogenase (LDH) in µmol/l*s
17. cholinesterase [ Time Frame: change from baseline after 2 weeks ]
    cholinesterase in µmol/l*s
18. kalium [ Time Frame: change from baseline after 2 weeks ]
    kalium in mmol/l
19. calcium [ Time Frame: change from baseline after 2 weeks ]
    calcium in mmol/l
20. transferrin [ Time Frame: change from baseline after 2 weeks ]
    transferrin (g/l)
21. ferritin [ Time Frame: change from baseline after 2 weeks ]
    ferritin (µg/l)
22. iron [ Time Frame: change from baseline after 2 weeks ]
    iron (mg/dl)
23. vitamin A [ Time Frame: change from baseline after 2 weeks ]
    vitamin A (mmol/l)
24. vitamin D [ Time Frame: change from baseline after 2 weeks ]
    vitamin D (nmol/l)
25. vitamin E [ Time Frame: change from baseline after 2 weeks ]
    vitamin E (µmol/l)
26. vitamin B1 [ Time Frame: change from baseline after 2 weeks ]
    vitamin B1 (nmol/l)
27. vitamin B6 [ Time Frame: change from baseline after 2 weeks ]
    vitamin B6 (nmol/l)
28. vitamin B12 [ Time Frame: change from baseline after 2 weeks ]
    vitamin B12 (pmol/l)
29. folic acid [ Time Frame: change from baseline after 2 weeks ]
    folic acid (µg/l)
30. vitamin B2 [ Time Frame: change from baseline after 2 weeks ]
    vitamin B2 (µg/l)
31. vitamin C [ Time Frame: change from baseline after 2 weeks ]
    vitamin C (mg/l)
32. vitamin H [ Time Frame: change from baseline after 2 weeks ]
    vitamin H (ng/l)
33. iodine (24 h urine) [ Time Frame: change from baseline after 2 weeks ]
    iodine (µmol/l)
34. selenium (24 h urine) [ Time Frame: change from baseline after 2 weeks ]
    selenium (µmol/l)
35. copper (24 h urine) [ Time Frame: change from baseline after 2 weeks ]
    copper (µmol/l)
36. zinc (24 h urine) [ Time Frame: change from baseline after 2 weeks ]
    zinc (µmol/l)
37. manganese (24 h urine) [ Time Frame: change from baseline after 2 weeks ]
    manganese (nmol/l)
38. natrium (24 h urine) [ Time Frame: change from baseline after 2 weeks ]
    natrium (mmol/l)
39. magnesium (24 h urine) [ Time Frame: change from baseline after 2 weeks ]
    magnesium (mmol/l)
40. creatinine (24 h urine) [ Time Frame: change from baseline after 2 weeks ]
    creatinine (mmol/24 h)
41. albumine (24 h urine) [ Time Frame: change from baseline after 2 weeks ]
    albumine (mg/l)
42. uric acid (24 h urine) [ Time Frame: change from baseline after 2 weeks ]
    uric acid (mg/dl)

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Germany

Friedrich Schiller University

Jena, Thuringia, Germany, 07743

Sponsors and Collaborators

University of Jena

German Federal Ministry of Education and Research

More Information

• Responsible Party: Christine Dawczynski,PhD, Study leader, University of Jena
• ClinicalTrials.gov Identifier: NCT04567823
• Other Study ID Numbers: H10_20
• First Posted: September 29, 2020
• Last Update Posted: January 13, 2021
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christine Dawczynski,PhD, University of Jena:

microalgae; omega-3 fatty acids; vitamins; minerals; trace elements