Effect of Chitin and Ascorbic Acid on Dietary Insect Iron Absorption (INSECTE)

The Effect of Chitin and Ascorbic Acid on Dietary Iron Absorption From Tenebrio Molitor Larvae in Young Women.

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

25

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 Contact

Study Locations

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T.molitor native chitin
Vegetable soup prepared with dried 57-Fe intrinsically labeled T.molitor
Vegetable soup prepared with dried intrinsically labeled T.molitor (isotopic iron 57, native chitin content = 1g)
Experimental: T.molitor high chitin level
Vegetable soup prepared with dried 57-Fe intrinsically labeled T.molitor + 2g chitin of shrimp origin
Vegetable soup prepared with dried intrinsically labeled T.molitor (isotopic iron 57) + 2g of extrinsically added chitin
Experimental: T.molitor + Ascorbic Acid
Vegetable soup prepared with dried 57-Fe intrinsically labeled T.molitor + Ascorbic acid (4:1 ascorbic acid to iron molar ratio)
Vegetable soup prepared with dried intrinsically labeled T.molitor (isotopic iron 57) + ascorbic acid (4:1 ascorbic acid to iron molar ratio)
Experimental: Control meal
Vegetable soup with addition of labelled FeSO4 (isotope iron 58)
Vegetable soup without insects with extrinsic addition of FeSO4 (isotopic iron 58)
Experimental: Control meal low chitin
Vegetable soup with addition of labelled FeSO4 (isotope iron 58) + 1g chitin of shrimp origin
Vegetable soup without insects with extrinsic addition of FeSO4 (isotopic iron 58) + 1g of extrinsically added chitin
Experimental: Control meal high chitin
Vegetable soup with addition of labelled FeSO4 (isotope iron 58) + 3g chitin of shrimp origin
Vegetable soup without insects with extrinsic addition of FeSO4 (isotopic iron 58) + 3g of extrinsically added chitin
Experimental: Control meal + Ascorbic Acid
Vegetable soup with addition of labelled FeSO4 (isotope iron 54) + Ascorbic acid (4:1 ascorbic acid to iron molar ratio)
Vegetable soup without insects with extrinsic addition of FeSO4 (isotopic iron 54) + ascorbic acid (4:1 ascorbic acid to iron molar ratio)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fractional iron absorption
Time Frame: screening (-1), 16th, 32nd,47th day of the study
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin (Hb)
Time Frame: screening (-1), 16th, 32nd, 47th day of the study
Iron status marker
screening (-1), 16th, 32nd, 47th day of the study
Serum Ferritin (SF)
Time Frame: screening (-1), 16th, 32nd, 47th day of the study
Iron status marker
screening (-1), 16th, 32nd, 47th day of the study
Serum Transferrin Receptor (sTfR)
Time Frame: screening (-1), 47th day of the study
Iron status marker
screening (-1), 47th day of the study
C-Reactive Protein (CRP)
Time Frame: screening (-1), 16th, 32nd, 47th day of the study
Inflammation status
screening (-1), 16th, 32nd, 47th day of the study
alpha-1-acid glycoprotein (AGP)
Time Frame: screening (-1), 47th day of the study
Inflammation status
screening (-1), 47th day of the study
Retinol binding Protein (RBP)
Time Frame: screening (-1), 47th day of the study
Inflammation status
screening (-1), 47th day of the study

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Diego Moretti, Prof., Fernfachhochschule Schweiz

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)

May 6, 2025

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

February 12, 2025

Study Record Updates

Last Update Posted (Actual)

May 31, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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