Iron Deficiency (Without Anemia)INSECTENCT06822062
Effect of Chitin and Ascorbic Acid on Dietary Insect Iron Absorption
A study testing Meal A, Meal B and Meal C in people with Iron Deficiency (Without Anemia), run by Swiss Distance University of Applied Sciences at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency (Without Anemia)
- What is being tested?
- Meal A, Meal B and Meal C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
ETH Zürich
Zurich, Canton of Zurich, 8005
0445120920, diego.moretti@ffhs.ch
Diego Moretti
About this study
Official title: 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.
- Conditions
- Iron Deficiency (Without Anemia)
- Being tested
- Meal A, Meal B, Meal C, Meal D, Meal E
- Keywords
- edible insects, Tenebrio molitor, iron deficiency, iron bioavailability, chitin, ascorbic acid
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal AOther
Vegetable soup prepared with dried intrinsically labeled T.molitor (isotopic iron 57, native chitin content = 1g)
Meal BOther
Vegetable soup prepared with dried intrinsically labeled T.molitor (isotopic iron 57) + 2g of extrinsically added chitin
Meal COther
Vegetable soup prepared with dried intrinsically labeled T.molitor (isotopic iron 57) + ascorbic acid (4:1 ascorbic acid to iron molar ratio)
Meal DOther
Vegetable soup without insects with extrinsic addition of FeSO4 (isotopic iron 58)
Meal EOther
Vegetable soup without insects with extrinsic addition of FeSO4 (isotopic iron 58) + 1g of extrinsically added chitin
Meal FOther
Vegetable soup without insects with extrinsic addition of FeSO4 (isotopic iron 58) + 3g of extrinsically added chitin
Meal GOther
Vegetable soup without insects with extrinsic addition of FeSO4 (isotopic iron 54) + ascorbic acid (4:1 ascorbic acid to iron molar ratio)
| Study group | Role | What they receive |
|---|---|---|
| T.molitor native chitin | Experimental | Vegetable soup prepared with dried 57-Fe intrinsically labeled T.molitor Receives: 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 Receives: 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) Receives: Other: Meal C |
| Control meal | Experimental | Vegetable soup with addition of labelled FeSO4 (isotope iron 58) Receives: Other: Meal D |
| Control meal low chitin | Experimental | Vegetable soup with addition of labelled FeSO4 (isotope iron 58) + 1g chitin of shrimp origin Receives: Other: Meal E |
| Control meal high chitin | Experimental | Vegetable soup with addition of labelled FeSO4 (isotope iron 58) + 3g chitin of shrimp origin Receives: 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) Receives: Other: Meal G |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: screening (-1), 16th, 32nd,47th day of the study
Secondary outcomes (6)
Hemoglobin (Hb)
Iron status marker
Measured: screening (-1), 16th, 32nd, 47th day of the study
Serum Ferritin (SF)
Iron status marker
Measured: screening (-1), 16th, 32nd, 47th day of the study
Serum Transferrin Receptor (sTfR)
Iron status marker
Measured: screening (-1), 47th day of the study
C-Reactive Protein (CRP)
Inflammation status
Measured: screening (-1), 16th, 32nd, 47th day of the study
alpha-1-acid glycoprotein (AGP)
Inflammation status
Measured: screening (-1), 47th day of the study
Retinol binding Protein (RBP)
Inflammation status
Measured: screening (-1), 47th day of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start6 May 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency (Without Anemia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study will be a single-center, prospective cross-over trial, in which all study participant will receive the seven test conditions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Distance University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Diego Moretti, Prof., Principal investigator, Fernfachhochschule Schweiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822062
- Sponsor's protocol ID
- INSECTE_01
- Acronym
- INSECTE
- Status last verified
- May 2025
- First submitted
- 6 Feb 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chitin and Ascorbic Acid on Dietary Iron Absorption From Tenebrio Molitor Larvae in Young Women.
- ClinicalTrials.gov ID
- NCT06822062
- Acronym / sponsor ID
- INSECTE / INSECTE_01
- Conditions
- Iron Deficiency (Without Anemia)
- Keywords
- edible insects, Tenebrio molitor, iron deficiency, iron bioavailability, chitin, ascorbic acid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Swiss Distance University of Applied SciencesUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Study start
- 6 May 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 7
- Model description
- The study will be a single-center, prospective cross-over trial, in which all study participant will receive the seven test conditions.
| Arm | Type | Receives |
|---|---|---|
| T.molitor native chitin | Experimental | Other: Meal AVegetable soup prepared with dried 57-Fe intrinsically labeled T.molitor |
| T.molitor high chitin level | Experimental | Other: Meal BVegetable soup prepared with dried 57-Fe intrinsically labeled T.molitor + 2g chitin of shrimp origin |
| T.molitor + Ascorbic Acid | Experimental | Other: Meal CVegetable soup prepared with dried 57-Fe intrinsically labeled T.molitor + Ascorbic acid (4:1 ascorbic acid to iron molar ratio) |
| Control meal | Experimental | Other: Meal DVegetable soup with addition of labelled FeSO4 (isotope iron 58) |
| Control meal low chitin | Experimental | Other: Meal EVegetable soup with addition of labelled FeSO4 (isotope iron 58) + 1g chitin of shrimp origin |
| Control meal high chitin | Experimental | Other: Meal FVegetable soup with addition of labelled FeSO4 (isotope iron 58) + 3g chitin of shrimp origin |
| Control meal + Ascorbic Acid | Experimental | Other: Meal GVegetable soup with addition of labelled FeSO4 (isotope iron 54) + Ascorbic acid (4:1 ascorbic acid to iron molar ratio) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meal AVegetable soup prepared with dried intrinsically labeled T.molitor (isotopic iron 57, native chitin content = 1g) | Other | T.molitor native chitin |
| Meal BVegetable soup prepared with dried intrinsically labeled T.molitor (isotopic iron 57) + 2g of extrinsically added chitin | Other | T.molitor high chitin level |
| Meal CVegetable soup prepared with dried intrinsically labeled T.molitor (isotopic iron 57) + ascorbic acid (4:1 ascorbic acid to iron molar ratio) | Other | T.molitor + Ascorbic Acid |
| Meal DVegetable soup without insects with extrinsic addition of FeSO4 (isotopic iron 58) | Other | Control meal |
| Meal EVegetable soup without insects with extrinsic addition of FeSO4 (isotopic iron 58) + 1g of extrinsically added chitin | Other | Control meal low chitin |
| Meal FVegetable soup without insects with extrinsic addition of FeSO4 (isotopic iron 58) + 3g of extrinsically added chitin | Other | Control meal high chitin |
| Meal GVegetable soup without insects with extrinsic addition of FeSO4 (isotopic iron 54) + ascorbic acid (4:1 ascorbic acid to iron molar ratio) | Other | Control meal + Ascorbic Acid |
Primary outcome
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.
6 secondary outcomes
Hemoglobin (Hb)
Time frame: screening (-1), 16th, 32nd, 47th day of the study
Serum Ferritin (SF)
Time frame: screening (-1), 16th, 32nd, 47th day of the study
Serum Transferrin Receptor (sTfR)
Time frame: screening (-1), 47th day of the study
C-Reactive Protein (CRP)
Time frame: screening (-1), 16th, 32nd, 47th day of the study
alpha-1-acid glycoprotein (AGP)
Time frame: screening (-1), 47th day of the study
Retinol binding Protein (RBP)
Time frame: screening (-1), 47th day of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diego Moretti, Prof. principal investigator
Fernfachhochschule Schweiz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal A, Meal B and Meal C in people with Iron Deficiency (Without Anemia), run by Swiss Distance University of Applied Sciences at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diego Moretti, Prof. (+41 44 512 09 20, diego.moretti@ffhs.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional iron absorption (time frame: screening (-1), 16th, 32nd,47th day of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.