Measuring Dietary Iron Absorption From Edible Insects and Assessing the Effect of Chitin Content on Iron Bioavailability (Study 1) (Sustironable1)

June 9, 2022 updated by: Swiss Federal Institute of Technology

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

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zurich, Switzerland, 8092
        • ETH Zurich, Laboratory of Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Refined maize
Two portions of porridge prepared with refined maize flour with extrinsic addition of labelled FeSO4 (isotopic iron 54)
Porridge prepared with refined maize flour with extrinsic addition of FeSO4 (isotopic iron 54)
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)
Porridge prepared with dried intrinsically labelled T.molitor (isotopic iron 57) native chitin, refined maize flour and extrinsic addition FeSO4 (isotopic iron 58)
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)
Porridge prepared with dried intrinsically labelled T.molitor (isotopic iron 57) reduced chitin, refined maize flour and extrinsic addition FeSO4 (isotopic iron 58)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30th day of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin (Hb)
Time Frame: screening (-1), day 16th and day 30th of the study
Iron status marker
screening (-1), day 16th and day 30th of the study
Plasma ferritin (PF)
Time Frame: screening (-1), day 16th and day 30th of the study
Iron status marker
screening (-1), day 16th and day 30th of the study
C-Reactive Protein (CRP)
Time Frame: screening (-1), day 16th and day 30th of the study
Inflammation status
screening (-1), day 16th and day 30th of the study
Soluble transferring receptor (sTfR)
Time Frame: screening (-1), day 16th and day 30th of the study
Iron status marker
screening (-1), day 16th and day 30th of the study
Body iron stores (BIS)
Time Frame: screening (-1), day 16th and day 30th of the study
Iron status marker
screening (-1), day 16th and day 30th of the study
Alpha 1 acid glycoprotein (AGP)
Time Frame: screening (-1), day 16th and day 30th of the study
Inflammation marker
screening (-1), day 16th and day 30th of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nikolin Hilaj, MSc, Laboratory of Human Nutrition ETH Zürich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2020

Primary Completion (Actual)

December 8, 2020

Study Completion (Actual)

December 9, 2020

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 9, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

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

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.

Clinical Trials on Iron-deficiency

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