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

Primary Purpose

Iron-deficiency

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Refined maize with extrinsic addition of labelled FeSO4
T.molitor native chitin
T molitor reduced chitin
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Iron-deficiency focused on measuring chitin, iron deficiency, Tenebrio molitor, iron bioavailability, edible insects

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • ETH Zurich, Laboratory of Human Nutrition

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Refined maize

T.molitor native chitin

T.molitor reduced chitin

Arm Description

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

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hemoglobin (Hb)
Iron status marker
Plasma ferritin (PF)
Iron status marker
C-Reactive Protein (CRP)
Inflammation status
Soluble transferring receptor (sTfR)
Iron status marker
Body iron stores (BIS)
Iron status marker
Alpha 1 acid glycoprotein (AGP)
Inflammation marker

Full Information

First Posted
August 10, 2020
Last Updated
June 9, 2022
Sponsor
Swiss Federal Institute of Technology
Collaborators
Zurich University of Applied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04510831
Brief Title
Measuring Dietary Iron Absorption From Edible Insects and Assessing the Effect of Chitin Content on Iron Bioavailability (Study 1)
Acronym
Sustironable1
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
December 8, 2020 (Actual)
Study Completion Date
December 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
Zurich University of Applied Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency
Keywords
chitin, iron deficiency, Tenebrio molitor, iron bioavailability, edible insects

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Refined maize
Arm Type
Experimental
Arm Description
Two portions of porridge prepared with refined maize flour with extrinsic addition of labelled FeSO4 (isotopic iron 54)
Arm Title
T.molitor native chitin
Arm Type
Experimental
Arm Description
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)
Arm Title
T.molitor reduced chitin
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Refined maize with extrinsic addition of labelled FeSO4
Intervention Description
Porridge prepared with refined maize flour with extrinsic addition of FeSO4 (isotopic iron 54)
Intervention Type
Other
Intervention Name(s)
T.molitor native chitin
Intervention Description
Porridge prepared with dried intrinsically labelled T.molitor (isotopic iron 57) native chitin, refined maize flour and extrinsic addition FeSO4 (isotopic iron 58)
Intervention Type
Other
Intervention Name(s)
T molitor reduced chitin
Intervention Description
Porridge prepared with dried intrinsically labelled T.molitor (isotopic iron 57) reduced chitin, refined maize flour and extrinsic addition FeSO4 (isotopic iron 58)
Primary Outcome Measure Information:
Title
Fractional Iron absorption
Description
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 Outcome Measure Information:
Title
Hemoglobin (Hb)
Description
Iron status marker
Time Frame
screening (-1), day 16th and day 30th of the study
Title
Plasma ferritin (PF)
Description
Iron status marker
Time Frame
screening (-1), day 16th and day 30th of the study
Title
C-Reactive Protein (CRP)
Description
Inflammation status
Time Frame
screening (-1), day 16th and day 30th of the study
Title
Soluble transferring receptor (sTfR)
Description
Iron status marker
Time Frame
screening (-1), day 16th and day 30th of the study
Title
Body iron stores (BIS)
Description
Iron status marker
Time Frame
screening (-1), day 16th and day 30th of the study
Title
Alpha 1 acid glycoprotein (AGP)
Description
Inflammation marker
Time Frame
screening (-1), day 16th and day 30th of the study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolin Hilaj, MSc
Organizational Affiliation
Laboratory of Human Nutrition ETH Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
ETH Zurich, Laboratory of Human Nutrition
City
Zurich
ZIP/Postal Code
8092
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36100966
Citation
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.
Results Reference
derived

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

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