Effect of Chitin and Ascorbic Acid on Dietary Insect Iron Absorption

NCT06822062 | Recruiting DMC

• 1 other identifier: INSECTE_01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Iron is involved in many vital metabolic processes such as oxygen transport, electron transport in cells, DNA synthesis and repair, and muscle metabolism. However, iron deficiency and iron deficiency anemia continue to affect many people, particularly preschool children (\<5 years), adolescents, and pregnant and non-pregnant women of childbearing age. Iron deficiency is characterized by a lack of total iron stores in the body, which is mainly caused by insufficient dietary iron intake, physiologically increased iron requirements, poor intestinal iron absorption, or chronic blood loss. Animal foods are important sources of highly bioavailable iron in the human diet. Meeting human nutritional needs for the rapidly increasing world population while targeting food production within the planetary boundaries will require the identification of sustainable iron sources, such as edible insects. A previous iron absorption study showed that insect iron is absorbed moderately well. The present study will examine if and to which extent chitin, a polysaccharide within the insect biomass, inhibits iron absorption. In addition, the enhancing iron absorption of ascorbic acid on iron absorption from Tenebrio molitor larvae will be studied. This knowledge can support to optimize the composition of an insect-based meal to increase its iron absorption. To distinguish iron absorption from insect biomass from other sources, insects are labeled with stable iron isotopes (Fe-57, Fe-58, Fe-54) and iron absorption in the blood is measured.

Conditions

Iron Deficiency (Without Anemia)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Fractional iron absorption

  Fractional iron absorption will be calculated based on the shift in iron isotope ratio in red blood cells 14 to 16 days post administration of the isotopically labelled meals. Calculation of fractional iron absorption will take into account the principles of isotope dilution and the fact that iron isotopic labels are not monoisotopic.

  screening (-1), 16th, 32nd,47th day of the study

Secondary Outcomes (6)

• Hemoglobin (Hb)

  screening (-1), 16th, 32nd, 47th day of the study

• Serum Ferritin (SF)

  screening (-1), 16th, 32nd, 47th day of the study

• Serum Transferrin Receptor (sTfR)

  screening (-1), 47th day of the study

• C-Reactive Protein (CRP)

  screening (-1), 16th, 32nd, 47th day of the study

• alpha-1-acid glycoprotein (AGP)

  screening (-1), 47th day of the study

Study Arms (7)

T.molitor native chitin

EXPERIMENTAL

Vegetable soup prepared with dried 57-Fe intrinsically labeled T.molitor

Other: Meal A

T.molitor high chitin level

EXPERIMENTAL

Vegetable soup prepared with dried 57-Fe intrinsically labeled T.molitor + 2g chitin of shrimp origin

Other: Meal B

T.molitor + Ascorbic Acid

EXPERIMENTAL

Vegetable soup prepared with dried 57-Fe intrinsically labeled T.molitor + Ascorbic acid (4:1 ascorbic acid to iron molar ratio)

Other: Meal C

Control meal

EXPERIMENTAL

Vegetable soup with addition of labelled FeSO4 (isotope iron 58)

Other: Meal D

Control meal low chitin

EXPERIMENTAL

Vegetable soup with addition of labelled FeSO4 (isotope iron 58) + 1g chitin of shrimp origin

Other: Meal E

Control meal high chitin

EXPERIMENTAL

Vegetable soup with addition of labelled FeSO4 (isotope iron 58) + 3g chitin of shrimp origin

Other: Meal F

Control meal + Ascorbic Acid

EXPERIMENTAL

Vegetable soup with addition of labelled FeSO4 (isotope iron 54) + Ascorbic acid (4:1 ascorbic acid to iron molar ratio)

Other: Meal G

Interventions

Meal A OTHER

Vegetable soup prepared with dried intrinsically labeled T.molitor (isotopic iron 57, native chitin content = 1g)

T.molitor native chitin

Meal B OTHER

Vegetable soup prepared with dried intrinsically labeled T.molitor (isotopic iron 57) + 2g of extrinsically added chitin

T.molitor high chitin level

Meal C OTHER

Vegetable soup prepared with dried intrinsically labeled T.molitor (isotopic iron 57) + ascorbic acid (4:1 ascorbic acid to iron molar ratio)

T.molitor + Ascorbic Acid

Meal D OTHER

Vegetable soup without insects with extrinsic addition of FeSO4 (isotopic iron 58)

Control meal

Meal E OTHER

Vegetable soup without insects with extrinsic addition of FeSO4 (isotopic iron 58) + 1g of extrinsically added chitin

Control meal low chitin

Meal F OTHER

Vegetable soup without insects with extrinsic addition of FeSO4 (isotopic iron 58) + 3g of extrinsically added chitin

Control meal high chitin

Meal G OTHER

Vegetable soup without insects with extrinsic addition of FeSO4 (isotopic iron 54) + ascorbic acid (4:1 ascorbic acid to iron molar ratio)

Control meal + Ascorbic Acid

Eligibility Criteria

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

You may qualify if:

• Female aged between 18-45 years
• Normal BMI (18.5 - 24.9 kg/m2)
• Body weight \< 70 kg
• Low iron status (being in the lower half of the serum ferritin distribution at screening)

You may not qualify if:

• Anaemia (Hb \< 12 g/dL)
• Inflammation (CRP \> 5.0 mg/L)
• Pregnancy or intention to become pregnant during the study or within 30 days after the discontinuation of the study intervention
• Lactating up to 6 weeks before the study initiation
• Chronic digestive, renal and/or metabolic diseases
• Antibiotics in the last 4 weeks prior to the study and during the study
• Mineral and vitamin supplementation in the last 2 weeks prior to the study and during the course of the study
• Chronic medication intake (except for oral contraceptives)
• Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
• Earlier participation in a study using stable isotopes or in any clinical study within the last 30 days
• Food allergies, especially known hypersensitivity to crustacea, dust mites, sea food, gluten, milk, or eggs
• Cigarette smoking (\> 1 cigarette per day)

Sponsors & Collaborators

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

Study Sites (1)

ETH Zürich

Zurich, Canton of Zurich, 8005, Switzerland

RECRUITING

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Diego Moretti, Prof.

  Fernfachhochschule Schweiz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego Moretti, Prof.

CONTACT

+41 44 512 09 20; diego.moretti@ffhs.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The randomization will be single-blinded, i.e., the participants will not know which type of test meal they will be given on which study visit.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be a single-center, prospective cross-over trial, in which all study participant will receive the seven test conditions.

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 12, 2025
• Study Start: May 6, 2025
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

CH (1)