- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04510831
Measuring Dietary Iron Absorption From Edible Insects and Assessing the Effect of Chitin Content on Iron Bioavailability (Study 1) (Sustironable1)
Measuring Dietary Iron Absorption From Edible Insects and Assessing the Effect of Chitin Content on Iron Bioavailability: Stable Iron Isotope Studies in Young Women (Study 1, Tenebrio Molitor)
Due to the growing world population, there is a need to develop viable ecological and nutritional alternatives to animal food products. However, animal products are a key dietary source of well-absorbed iron, and iron deficiency and iron deficiency anemia remain highly prevalent in high- and low-income countries. Meat and fish provide a substantial proportion of absorbed iron in the western diet by two distinct components: a) heme iron is well absorbed (20-45% fractional absorption) and is not affected by most dietary enhancers and inhibitors, which often affect non-heme iron absorption; b) peptides in muscle meat exert an enhancing effect the absorption of non-heme iron contained in other meal components. The potential of edible insects as a dietary source of well-absorbed iron has not been investigated in detail. In particular, it is unclear whether insects provide an iron moiety similar to hemoglobin which would be well absorbed and unaffected by other dietary components, and whether their presence in a test meal exerts an enhancing effect on iron bioavailability from the whole meal.
Furthermore, chitin, a major component of insect biomass, is a known iron binder and is potentially responsible for a decreased iron absorption from insect-based foods. Decreasing chitin content could allow the high amounts of iron in insects to be well-absorbed, and enhance the absorption of iron from plant-based foods. To differentiate iron absorption from insect biomass from other sources, insects will be intrinsically labelled with the stable iron isotope 57Fe, while other food iron components will be labelled with the iron isotope 58Fe.The present study will provide novel data to elucidate the nutritional value as sources of dietary iron of insect species (Tenebrio molitor). Since 2017 T.molitor is recognised as an edible insect in the Swiss food legislation and commercially available (Essento Food AG, Zürich; Insekterei, GmbH, Zürich).
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zurich, Switzerland, 8092
- ETH Zurich, Laboratory of Human Nutrition
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female, 18 to 45 years old
- Normal Body Mass Index (18.5 - 25 kg/m2)
- Body weight ≤ 65 kg
- Non-anemic (hemoglobin (Hb) >12.0 g/dL)
- Low iron status (being in the lower half of the serum ferritin distribution at screening)
- Normal CRP (<5.0 mg/L), indicating no inflammation
- Knowledge of English at least at level B2 (assessed by self-declaration)
- Signed informed consent
Exclusion Criteria:
- Pregnancy (assessed by self-declaration)
- Lactating up to 6 weeks before study initiation
- Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
- Continuous/long-term use of medication (except for oral contraceptives and anti-acne medication)
- Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration
- Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
- Earlier participation in a study using iron stable isotopes or participation in any clinical study within the last 30 days
- Participant who cannot be expected to comply with study protocol e.g. not available on certain study appointments
- Cigarette smoking ( > 1 cigarette per day)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Refined maize
Two portions of porridge prepared with refined maize flour with extrinsic addition of labelled FeSO4 (isotopic iron 54)
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Porridge prepared with refined maize flour with extrinsic addition of FeSO4 (isotopic iron 54)
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Experimental: T.molitor native chitin
Two portions of porridge prepared with refined maize flour mixed with dried intrinsically labelled Tenebrio molitor (isotopic iron 57) native chitin and extrinsic addition FeSO4 (isotopic iron 58)
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Porridge prepared with dried intrinsically labelled T.molitor (isotopic iron 57) native chitin, refined maize flour and extrinsic addition FeSO4 (isotopic iron 58)
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Experimental: T.molitor reduced chitin
Two portions of porridge prepared with refined maize flour mixed with dried intrinsically labelled Tenebrio molitor (isotopic iron 57) reduced chitin and extrinsic addition FeSO4 (isotopic iron 58)
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Porridge prepared with dried intrinsically labelled T.molitor (isotopic iron 57) reduced chitin, refined maize flour and extrinsic addition FeSO4 (isotopic iron 58)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Fractional Iron absorption
Time Frame: 30th day of the study
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Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products .Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
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30th day of the study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Hemoglobin (Hb)
Time Frame: screening (-1), day 16th and day 30th of the study
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Iron status marker
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screening (-1), day 16th and day 30th of the study
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Plasma ferritin (PF)
Time Frame: screening (-1), day 16th and day 30th of the study
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Iron status marker
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screening (-1), day 16th and day 30th of the study
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C-Reactive Protein (CRP)
Time Frame: screening (-1), day 16th and day 30th of the study
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Inflammation status
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screening (-1), day 16th and day 30th of the study
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Soluble transferring receptor (sTfR)
Time Frame: screening (-1), day 16th and day 30th of the study
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Iron status marker
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screening (-1), day 16th and day 30th of the study
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Body iron stores (BIS)
Time Frame: screening (-1), day 16th and day 30th of the study
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Iron status marker
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screening (-1), day 16th and day 30th of the study
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Alpha 1 acid glycoprotein (AGP)
Time Frame: screening (-1), day 16th and day 30th of the study
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Inflammation marker
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screening (-1), day 16th and day 30th of the study
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nikolin Hilaj, MSc, Laboratory of Human Nutrition ETH Zürich
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sust-iron-able1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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