Nutrient Bioavailability From Microalgae (NovAL)

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.

Study Overview

• Status: Completed
• Conditions: Nutrient Deficiency
• Intervention / Treatment: Dietary supplement: Smoothie with microalgae

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Thuringia
    • Jena, Thuringia, Germany, 07743
      • Friedrich Schiller University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Jena
• Collaborators: German Federal Ministry of Education and Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 9, 2020
• Primary Completion (ACTUAL): December 12, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (ACTUAL): September 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: omega-3 fatty acids; vitamins; minerals; microalgae; trace elements
• Other Study ID Numbers: H10_20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No