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OpenTrials
Completed

NCT Number: NCT04567823

Nutrient Bioavailability From Microalgae

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.

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Key information

Conditions

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friedrich Schiller University

Jena, Thuringia, 07743, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smoothie with microalgae

Dietary Supplement

Smoothie with microalgae I: Chlorella pyrenoidosa, Smoothie with microalgae II: Nannochloropsis salina, Smoothie without microalgae

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

Human Intervention Study for Validating Nutrient Bioavailability From Microalgae

Acronym: NovAL

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 29, 2020
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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