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NCT Number: NCT04510831

Measuring Dietary Iron Absorption From Edible Insects and Assessing the Effect of Chitin Content on Iron Bioavailability (Study 1)

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).

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ETH Zurich, Laboratory of Human Nutrition

Zurich, 8092, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Refined maize with extrinsic addition of labelled FeSO4

Other

Porridge prepared with refined maize flour with extrinsic addition of FeSO4 (isotopic iron 54)

T.molitor native chitin

Other

Porridge prepared with dried intrinsically labelled T.molitor (isotopic iron 57) native chitin, refined maize flour and extrinsic addition FeSO4 (isotopic iron 58)

T molitor reduced chitin

Other

Porridge prepared with dried intrinsically labelled T.molitor (isotopic iron 57) reduced chitin, refined maize flour and extrinsic addition FeSO4 (isotopic iron 58)

Primary outcomes

  1. Fractional Iron absorption

    Time frame: 30th day of the study

    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.

Secondary outcomes

  1. Hemoglobin (Hb)

    Time frame: screening (-1), day 16th and day 30th of the study

    Iron status marker

  2. Plasma ferritin (PF)

    Time frame: screening (-1), day 16th and day 30th of the study

    Iron status marker

  3. C-Reactive Protein (CRP)

    Time frame: screening (-1), day 16th and day 30th of the study

    Inflammation status

  4. Soluble transferring receptor (sTfR)

    Time frame: screening (-1), day 16th and day 30th of the study

    Iron status marker

  5. Body iron stores (BIS)

    Time frame: screening (-1), day 16th and day 30th of the study

    Iron status marker

  6. Alpha 1 acid glycoprotein (AGP)

    Time frame: screening (-1), day 16th and day 30th of the study

    Inflammation marker

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Zurich University of Applied Sciences

Registry information

Official study title

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)

Acronym: Sustironable1

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 12, 2020
Registry last updated
Jun 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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