Nutrient Bioavailability From Microalgae

NCT04567823 | Completed

• 1 other identifier: H10_20
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrient Deficiency

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (42)

• blood lipids

  change from baseline after 2 weeks

• anthropometric data

  change from baseline after 2 weeks

• body mass index

  change from baseline after 2 weeks

• blood pressure

  change from baseline after 2 weeks

• inflammation marker (blood)

  change from baseline after 2 weeks

Study Arms (4)

Microalgae I

EXPERIMENTAL

Smoothie (enriched with Chlorella pyrenoidosa) and standardised background diet (defined menu plans)

Dietary Supplement: Smoothie with microalgae

Microalgae II

EXPERIMENTAL

Smoothie (enriched with Nannochloropsis salina) and standardised background diet (defined menu plans)

Dietary Supplement: Smoothie with microalgae

Smoothie

PLACEBO COMPARATOR

Smoothie (without microalgae) and standardised background diet (defined menu plans)

Dietary Supplement: Smoothie with microalgae

Control

NO INTERVENTION

no intervention (no smoothie, no menu plans)

Interventions

Smoothie with microalgae DIETARY_SUPPLEMENT

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

Microalgae I; Microalgae II; Smoothie

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jena: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (1)

Friedrich Schiller University

Jena, Thuringia, 07743, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: It is not visible whether the smoothie is fortified with microalgae or not.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study leader

Model Details: parallel design

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 29, 2020
• Study Start: November 9, 2020
• Primary Completion: December 12, 2020
• Study Completion: December 31, 2020
• Last Updated: January 13, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)