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

NCT04510831 | Completed DMC

• 1 other identifier: Sust-iron-able1
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Iron-deficiency

Keywords

chitin; iron deficiency; Tenebrio molitor; iron bioavailability; edible insects

Outcome Measures

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.

  30th day of the study

Secondary Outcomes (6)

• Hemoglobin (Hb)

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

• Plasma ferritin (PF)

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

• C-Reactive Protein (CRP)

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

• Soluble transferring receptor (sTfR)

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

• Body iron stores (BIS)

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

Study Arms (3)

Refined maize

EXPERIMENTAL

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

T.molitor native chitin

EXPERIMENTAL

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

T.molitor reduced chitin

EXPERIMENTAL

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

Refined maize with extrinsic addition of labelled FeSO4 OTHER

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

Refined maize

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 native chitin

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)

T.molitor reduced chitin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Zurich University of Applied Sciences: collaborator

Study Sites (1)

ETH Zurich, Laboratory of Human Nutrition

Zurich, 8092, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 36100966 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nikolin Hilaj, MSc

  Laboratory of Human Nutrition ETH Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: October 26, 2020
• Primary Completion: December 8, 2020
• Study Completion: December 9, 2020
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)