Nutrient DeficiencyNovALNCT04567823
Nutrient Bioavailability From Microalgae
A study testing Smoothie with microalgae in people with Nutrient Deficiency, run by University of Jena at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrient Deficiency
- What is being tested?
- Smoothie with microalgae
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 9 Nov 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Intervention Study for Validating 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.
Read the 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
- Being tested
- Smoothie with microalgae
- Keywords
- microalgae, omega-3 fatty acids, vitamins, minerals, trace elements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoothie with microalgaeDietary supplement
Smoothie with microalgae I: Chlorella pyrenoidosa, Smoothie with microalgae II: Nannochloropsis salina, Smoothie without microalgae
| Study group | Role | What they receive |
|---|---|---|
| Microalgae I | Experimental | Smoothie (enriched with Chlorella pyrenoidosa) and standardised background diet (defined menu plans) Receives: Dietary Supplement: Smoothie with microalgae |
| Microalgae II | Experimental | Smoothie (enriched with Nannochloropsis salina) and standardised background diet (defined menu plans) Receives: Dietary Supplement: Smoothie with microalgae |
| Smoothie | Placebo comparator | Smoothie (without microalgae) and standardised background diet (defined menu plans) Receives: Dietary Supplement: Smoothie with microalgae |
| Control | No intervention | no intervention (no smoothie, no menu plans) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EPA concentration in plasma lipids
concentration of eicosapentaenoic acid (EPA) in % fatty acid methyl esthers (FAME) in plasma lipids
Measured: change from baseline after 2 weeks
Secondary outcomes (42)
blood lipids
total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides in mmol/l
Measured: change from baseline after 2 weeks
anthropometric data
body water, body fat, lean body mass, extracellular mass (ECM), body cell mass (BCM) in %
Measured: change from baseline after 2 weeks
body mass index
body mass index (kg/m2)
Measured: change from baseline after 2 weeks
blood pressure
systolic blood pressure (mm Hg) diastolic blood pressure (mmHg)
Measured: change from baseline after 2 weeks
inflammation marker (blood)
high-sensitive c-reactive protein (mg/dl)
Measured: change from baseline after 2 weeks
homocysteine
homocysteine (µmol/l)
Measured: change from baseline after 2 weeks
holotranscobalamine
holotranscobalamine (pmol/l)
Measured: change from baseline after 2 weeks
glucose (fasting)
glucose (fasting) (mmol/l)
Measured: change from baseline after 2 weeks
insulin (fasting)
insulin (fasting) (mU/l)
Measured: change from baseline after 2 weeks
hemoglobin A1c (fasting)
hemoglobin A1c (fasting) (%)
Measured: change from baseline after 2 weeks
malodialdehyde modified LDL cholesterol
malodialdehyde modified LDL cholesterol (U/l)
Measured: change from baseline after 2 weeks
fatty acid distribution in plasma lipids
fatty acid distribution in plasma lipids in % FAME
Measured: change from baseline after 2 weeks
aspartate transaminase
aspartate transaminase (ASAT) in µmol/l*s
Measured: change from baseline after 2 weeks
alanine transaminase
alanine transaminase (ALAT) in µmol/l*s
Measured: change from baseline after 2 weeks
gamma-glutamyltransferase
gamma-glutamyltransferase (gGT) in µmol/l*s
Measured: change from baseline after 2 weeks
lactate dehydrogenase
lactate dehydrogenase (LDH) in µmol/l*s
Measured: change from baseline after 2 weeks
cholinesterase
cholinesterase in µmol/l*s
Measured: change from baseline after 2 weeks
kalium
kalium in mmol/l
Measured: change from baseline after 2 weeks
calcium
calcium in mmol/l
Measured: change from baseline after 2 weeks
transferrin
transferrin (g/l)
Measured: change from baseline after 2 weeks
ferritin
ferritin (µg/l)
Measured: change from baseline after 2 weeks
iron
iron (mg/dl)
Measured: change from baseline after 2 weeks
vitamin A
vitamin A (mmol/l)
Measured: change from baseline after 2 weeks
vitamin D
vitamin D (nmol/l)
Measured: change from baseline after 2 weeks
vitamin E
vitamin E (µmol/l)
Measured: change from baseline after 2 weeks
vitamin B1
vitamin B1 (nmol/l)
Measured: change from baseline after 2 weeks
vitamin B6
vitamin B6 (nmol/l)
Measured: change from baseline after 2 weeks
vitamin B12
vitamin B12 (pmol/l)
Measured: change from baseline after 2 weeks
folic acid
folic acid (µg/l)
Measured: change from baseline after 2 weeks
vitamin B2
vitamin B2 (µg/l)
Measured: change from baseline after 2 weeks
vitamin C
vitamin C (mg/l)
Measured: change from baseline after 2 weeks
vitamin H
vitamin H (ng/l)
Measured: change from baseline after 2 weeks
iodine (24 h urine)
iodine (µmol/l)
Measured: change from baseline after 2 weeks
selenium (24 h urine)
selenium (µmol/l)
Measured: change from baseline after 2 weeks
copper (24 h urine)
copper (µmol/l)
Measured: change from baseline after 2 weeks
zinc (24 h urine)
zinc (µmol/l)
Measured: change from baseline after 2 weeks
manganese (24 h urine)
manganese (nmol/l)
Measured: change from baseline after 2 weeks
natrium (24 h urine)
natrium (mmol/l)
Measured: change from baseline after 2 weeks
magnesium (24 h urine)
magnesium (mmol/l)
Measured: change from baseline after 2 weeks
creatinine (24 h urine)
creatinine (mmol/24 h)
Measured: change from baseline after 2 weeks
albumine (24 h urine)
albumine (mg/l)
Measured: change from baseline after 2 weeks
uric acid (24 h urine)
uric acid (mg/dl)
Measured: change from baseline after 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start9 Nov 2020
- Primary completion12 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrient DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Christine Dawczynski,PhD, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567823
- Sponsor's protocol ID
- H10_20
- Acronym
- NovAL
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Intervention Study for Validating Nutrient Bioavailability From Microalgae
- ClinicalTrials.gov ID
- NCT04567823
- Acronym / sponsor ID
- NovAL / H10_20
- Conditions
- Nutrient Deficiency
- Keywords
- microalgae, omega-3 fatty acids, vitamins, minerals, trace elements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- parallel design
| Arm | Type | Receives |
|---|---|---|
| Microalgae I | Experimental | Dietary Supplement: Smoothie with microalgaeSmoothie (enriched with Chlorella pyrenoidosa) and standardised background diet (defined menu plans) |
| Microalgae II | Experimental | Dietary Supplement: Smoothie with microalgaeSmoothie (enriched with Nannochloropsis salina) and standardised background diet (defined menu plans) |
| Smoothie | Placebo comparator | Dietary Supplement: Smoothie with microalgaeSmoothie (without microalgae) and standardised background diet (defined menu plans) |
| Control | No intervention | –no intervention (no smoothie, no menu plans) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoothie with microalgaeSmoothie with microalgae I: Chlorella pyrenoidosa, Smoothie with microalgae II: Nannochloropsis salina, Smoothie without microalgae | Dietary supplement | Microalgae I, Microalgae II, Smoothie |
Primary outcome
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
42 secondary outcomes
blood lipids
Time frame: change from baseline after 2 weeks
anthropometric data
Time frame: change from baseline after 2 weeks
body mass index
Time frame: change from baseline after 2 weeks
blood pressure
Time frame: change from baseline after 2 weeks
inflammation marker (blood)
Time frame: change from baseline after 2 weeks
homocysteine
Time frame: change from baseline after 2 weeks
holotranscobalamine
Time frame: change from baseline after 2 weeks
glucose (fasting)
Time frame: change from baseline after 2 weeks
insulin (fasting)
Time frame: change from baseline after 2 weeks
hemoglobin A1c (fasting)
Time frame: change from baseline after 2 weeks
malodialdehyde modified LDL cholesterol
Time frame: change from baseline after 2 weeks
fatty acid distribution in plasma lipids
Time frame: change from baseline after 2 weeks
aspartate transaminase
Time frame: change from baseline after 2 weeks
alanine transaminase
Time frame: change from baseline after 2 weeks
gamma-glutamyltransferase
Time frame: change from baseline after 2 weeks
lactate dehydrogenase
Time frame: change from baseline after 2 weeks
cholinesterase
Time frame: change from baseline after 2 weeks
kalium
Time frame: change from baseline after 2 weeks
calcium
Time frame: change from baseline after 2 weeks
transferrin
Time frame: change from baseline after 2 weeks
ferritin
Time frame: change from baseline after 2 weeks
iron
Time frame: change from baseline after 2 weeks
vitamin A
Time frame: change from baseline after 2 weeks
vitamin D
Time frame: change from baseline after 2 weeks
vitamin E
Time frame: change from baseline after 2 weeks
vitamin B1
Time frame: change from baseline after 2 weeks
vitamin B6
Time frame: change from baseline after 2 weeks
vitamin B12
Time frame: change from baseline after 2 weeks
folic acid
Time frame: change from baseline after 2 weeks
vitamin B2
Time frame: change from baseline after 2 weeks
vitamin C
Time frame: change from baseline after 2 weeks
vitamin H
Time frame: change from baseline after 2 weeks
iodine (24 h urine)
Time frame: change from baseline after 2 weeks
selenium (24 h urine)
Time frame: change from baseline after 2 weeks
copper (24 h urine)
Time frame: change from baseline after 2 weeks
zinc (24 h urine)
Time frame: change from baseline after 2 weeks
manganese (24 h urine)
Time frame: change from baseline after 2 weeks
natrium (24 h urine)
Time frame: change from baseline after 2 weeks
magnesium (24 h urine)
Time frame: change from baseline after 2 weeks
creatinine (24 h urine)
Time frame: change from baseline after 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoothie with microalgae in people with Nutrient Deficiency, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EPA concentration in plasma lipids (time frame: change from baseline after 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.