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CompletedNCT04510831Sustironable1Updated Jun 13, 2022

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

An interventional study of Refined maize with extrinsic addition of labelled FeSO4 and T.molitor native chitin in Iron-deficiency, sponsored by Swiss Federal Institute of Technology. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-13.

Sponsored by Swiss Federal Institute of Technology · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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).

02

Conditions studied

  • Iron-deficiency

Keywords

  • chitin
  • iron deficiency
  • Tenebrio molitor
  • iron bioavailability
  • edible insects
03

In context

Anemia, Iron-Deficiency

644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.

This study's enrollment of 21 is below the median of 100 across 503 interventional studies indexed under Anemia, Iron-Deficiency.

Browse Anemia, Iron-Deficiency studies →

Lead sponsor

Swiss Federal Institute of Technology is the lead sponsor of 152 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Refined maize

    Two portions of porridge prepared with refined maize flour with extrinsic addition of labelled FeSO4 (isotopic iron 54)

    Other: Refined maize with extrinsic addition of labelled FeSO4

  • 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)

    Other: T.molitor native chitin

  • 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)

    Other: T molitor reduced chitin

Interventions

  • OtherRefined maize with extrinsic addition of labelled FeSO4

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

  • OtherT.molitor native chitin

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

  • OtherT molitor reduced chitin

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

06

What researchers measure

Primary outcomes

  1. Fractional Iron absorption

    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.

    Time frame: 30th day of the study

Secondary outcomes

  1. Hemoglobin (Hb)

    Iron status marker

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

  2. Plasma ferritin (PF)

    Iron status marker

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

  3. C-Reactive Protein (CRP)

    Inflammation status

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

  4. Soluble transferring receptor (sTfR)

    Iron status marker

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

  5. Body iron stores (BIS)

    Iron status marker

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

  6. Alpha 1 acid glycoprotein (AGP)

    Inflammation marker

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

07

Study locations

1 site
  • ETH Zurich, Laboratory of Human Nutrition
    Zurich, 8092, Switzerland
08

References and documents

Publications

  • Hilaj N, Zimmermann MB, Galetti V, Zeder C, Murad Lima R, Hammer L, Krzystek A, Andlauer W, Moretti D. The effect of dechitinization on iron absorption from mealworm larvae (Tenebrio molitor) flour added to maize meals: stable-isotope studies in young females with low iron stores. Am J Clin Nutr. 2022 Oct 6;116(4):1135-1145. doi: 10.1093/ajcn/nqac210. PubMed 36100966 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04510831
Lead sponsor
Swiss Federal Institute of Technology
Collaborators
Zurich University of Applied Sciences
Responsible party
Sponsor
First posted
Aug 12, 2020
Start date
Oct 26, 2020
Primary completion
Dec 8, 2020
Completion
Dec 9, 2020
Last update
Jun 13, 2022

Study contacts

Nikolin Hilaj, MSc
principal investigator · Laboratory of Human Nutrition ETH Zürich

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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