Nutrient Bioavailability From Microalgae

Nutrient Deficiency Clinical Trial

— NovAL  

Official title:

Human Intervention Study for Validating Nutrient Bioavailability From Microalgae

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04567823
• Other study ID #: H10_20
• Status: Completed
• Phase: N/A
• Start date: November 9, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2020
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2020
• Est. primary completion date: December 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Nutrient Deficiency

Intervention

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

Locations

Country	Name	City	State
Germany	Friedrich Schiller University	Jena	Thuringia

Sponsors (2)

Lead Sponsor	Collaborator
University of Jena	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EPA concentration in plasma lipids	concentration of eicosapentaenoic acid (EPA) in % fatty acid methyl esthers (FAME) in plasma lipids	change from baseline after 2 weeks
Secondary	blood lipids	total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides in mmol/l	change from baseline after 2 weeks
Secondary	anthropometric data	body water, body fat, lean body mass, extracellular mass (ECM), body cell mass (BCM) in %	change from baseline after 2 weeks
Secondary	body mass index	body mass index (kg/m2)	change from baseline after 2 weeks
Secondary	blood pressure	systolic blood pressure (mm Hg) diastolic blood pressure (mmHg)	change from baseline after 2 weeks
Secondary	inflammation marker (blood)	high-sensitive c-reactive protein (mg/dl)	change from baseline after 2 weeks
Secondary	homocysteine	homocysteine (µmol/l)	change from baseline after 2 weeks
Secondary	holotranscobalamine	holotranscobalamine (pmol/l)	change from baseline after 2 weeks
Secondary	glucose (fasting)	glucose (fasting) (mmol/l)	change from baseline after 2 weeks
Secondary	insulin (fasting)	insulin (fasting) (mU/l)	change from baseline after 2 weeks
Secondary	hemoglobin A1c (fasting)	hemoglobin A1c (fasting) (%)	change from baseline after 2 weeks
Secondary	malodialdehyde modified LDL cholesterol	malodialdehyde modified LDL cholesterol (U/l)	change from baseline after 2 weeks
Secondary	fatty acid distribution in plasma lipids	fatty acid distribution in plasma lipids in % FAME	change from baseline after 2 weeks
Secondary	aspartate transaminase	aspartate transaminase (ASAT) in µmol/l*s	change from baseline after 2 weeks
Secondary	alanine transaminase	alanine transaminase (ALAT) in µmol/l*s	change from baseline after 2 weeks
Secondary	gamma-glutamyltransferase	gamma-glutamyltransferase (gGT) in µmol/l*s	change from baseline after 2 weeks
Secondary	lactate dehydrogenase	lactate dehydrogenase (LDH) in µmol/l*s	change from baseline after 2 weeks
Secondary	cholinesterase	cholinesterase in µmol/l*s	change from baseline after 2 weeks
Secondary	kalium	kalium in mmol/l	change from baseline after 2 weeks
Secondary	calcium	calcium in mmol/l	change from baseline after 2 weeks
Secondary	transferrin	transferrin (g/l)	change from baseline after 2 weeks
Secondary	ferritin	ferritin (µg/l)	change from baseline after 2 weeks
Secondary	iron	iron (mg/dl)	change from baseline after 2 weeks
Secondary	vitamin A	vitamin A (mmol/l)	change from baseline after 2 weeks
Secondary	vitamin D	vitamin D (nmol/l)	change from baseline after 2 weeks
Secondary	vitamin E	vitamin E (µmol/l)	change from baseline after 2 weeks
Secondary	vitamin B1	vitamin B1 (nmol/l)	change from baseline after 2 weeks
Secondary	vitamin B6	vitamin B6 (nmol/l)	change from baseline after 2 weeks
Secondary	vitamin B12	vitamin B12 (pmol/l)	change from baseline after 2 weeks
Secondary	folic acid	folic acid (µg/l)	change from baseline after 2 weeks
Secondary	vitamin B2	vitamin B2 (µg/l)	change from baseline after 2 weeks
Secondary	vitamin C	vitamin C (mg/l)	change from baseline after 2 weeks
Secondary	vitamin H	vitamin H (ng/l)	change from baseline after 2 weeks
Secondary	iodine (24 h urine)	iodine (µmol/l)	change from baseline after 2 weeks
Secondary	selenium (24 h urine)	selenium (µmol/l)	change from baseline after 2 weeks
Secondary	copper (24 h urine)	copper (µmol/l)	change from baseline after 2 weeks
Secondary	zinc (24 h urine)	zinc (µmol/l)	change from baseline after 2 weeks
Secondary	manganese (24 h urine)	manganese (nmol/l)	change from baseline after 2 weeks
Secondary	natrium (24 h urine)	natrium (mmol/l)	change from baseline after 2 weeks
Secondary	magnesium (24 h urine)	magnesium (mmol/l)	change from baseline after 2 weeks
Secondary	creatinine (24 h urine)	creatinine (mmol/24 h)	change from baseline after 2 weeks
Secondary	albumine (24 h urine)	albumine (mg/l)	change from baseline after 2 weeks
Secondary	uric acid (24 h urine)	uric acid (mg/dl)	change from baseline after 2 weeks