Iron-deficiencySustironable2NCT05328141
Measuring Dietary Iron Absorption From Edible Insects and Assessing the Effect of Chitin Content on Iron Bioavailability (Study 2)
A study testing Bread and butter, X.gideon and X.gideon with ascorbic acid in people with Iron-deficiency, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial 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. 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
- What is being tested?
- Bread and butter, X.gideon and X.gideon with ascorbic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 May 2022to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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, 18 to 45 years old
- Normal Body Mass Index (18.5 - 25 kg/m2)
- Body weight ≤ 55 kg
- Non-anemic (hemoglobin (Hb) >12.0 g/dL)
- Serum Ferritin < 25 μg/L;
- Normal CRP (<5.0 mg/L), indicating no inflammation
- Knowledge of English at least at level B2 (assessed by self-declaration)
- Signed informed consent
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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 2, Xylotrupes Gideon)
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.
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 studiy will provide novel data to elucidate the nutritional value as sources of dietary iron of insect species Xylotrupes gideon. X. gideon is an insect species traditionally widely consumed in SubSaharan Africa and South East Asia and recognised by FAO as an edible insect species. X gideon is produced in ZHAW facilities in Linthal, Switzerland under controlled conditions aiming to a highly sustainable and high nutritional value food product. Furthermore the benefit of ascorbic acid addition to X.gideon biomass on iron absorption will be quantified.
- Conditions
- Iron-deficiency
- Being tested
- Bread and butter, X.gideon, X.gideon with ascorbic acid
- Keywords
- edible insects, iron bioavailability, ascorbic acid, Xylotrupes gideon
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bread and butterOther
A bread with butter meal without insect biomass with FeSO4 (isotopic iron 54)
X.gideonOther
Intrinsically labelled (57Fe) or non labelled X.gideon flour mixed with butter and sugar meal with FeSO4 (extrinsic label, isotopic iron 58)
X.gideon with ascorbic acidOther
Intrinsically labelled (57Fe) or non labelled X.gideon flour mixed with butter and sugar meal with FeSO4 (extrinsic label, isotopic iron 58) and ascorbic acid
| Study group | Role | What they receive |
|---|---|---|
| Bread and butter | Experimental | A toast bread with butter meal without insect biomass with FeSO4 (isotopic iron 54) Receives: Other: Bread and butter |
| X.gideon | Experimental | Intrinsically labelled (57Fe) or non labelled X.gideon flour mixed with butter and sugar meal with FeSO4 (extrinsic label, isotopic iron 58) Receives: Other: X.gideon |
| X.gideon with ascorbic acid | Experimental | Intrinsically labelled (57Fe) or non labelled X.gideon flour mixed with butter and sugar meal with FeSO4 (extrinsic label, isotopic iron 58) and ascorbic acid Receives: Other: X.gideon with ascorbic acid |
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 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.
Measured: 30th day of the study
Secondary outcomes (6)
Hemoglobin (Hb)
Iron status marker
Measured: screening (-1), day 16th and day 30th of the study
Plasma ferritin (PF)
Iron status marker
Measured: screening (-1), day 16th and day 30th of the study
C-Reactive Protein (CRP)
Inflammation status
Measured: screening (-1), day 16th and day 30th of the study
Soluble transferring receptor (sTfR)
Iron status marker
Measured: screening (-1), day 16th and day 30th of the study
Body iron stores (BIS)
Iron status marker
Measured: screening (-1), day 16th and day 30th of the study
Alpha 1 acid glycoprotein (AGP)
Inflammation marker
Measured: screening (-1), day 16th and day 30th 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 posted14 Apr 2022
- Study start20 May 2022
- Primary completion20 Jul 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Zurich University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Nikolin Hilaj, MSc, Principal investigator, Laboratory of Human Nutrition ETH Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328141
- Sponsor's protocol ID
- Sust-iron-able2
- Acronym
- Sustironable2
- Status last verified
- Jun 2022
- First submitted
- 7 Apr 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 2, Xylotrupes Gideon)
- ClinicalTrials.gov ID
- NCT05328141
- Acronym / sponsor ID
- Sustironable2 / Sust-iron-able2
- Conditions
- Iron-deficiency
- Keywords
- edible insects, iron bioavailability, ascorbic acid, Xylotrupes gideon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Zurich University of Applied Sciences
- Study start
- 20 May 2022 (actual)
- Primary completion
- 20 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 14 Apr 2022 (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.
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.
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 studiy will provide novel data to elucidate the nutritional value as sources of dietary iron of insect species Xylotrupes gideon. X. gideon is an insect species traditionally widely consumed in SubSaharan Africa and South East Asia and recognised by FAO as an edible insect species. X gideon is produced in ZHAW facilities in Linthal, Switzerland under controlled conditions aiming to a highly sustainable and high nutritional value food product. Furthermore the benefit of ascorbic acid addition to X.gideon biomass on iron absorption will be quantified.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bread and butter | Experimental | Other: Bread and butterA toast bread with butter meal without insect biomass with FeSO4 (isotopic iron 54) |
| X.gideon | Experimental | Other: X.gideonIntrinsically labelled (57Fe) or non labelled X.gideon flour mixed with butter and sugar meal with FeSO4 (extrinsic label, isotopic iron 58) |
| X.gideon with ascorbic acid | Experimental | Other: X.gideon with ascorbic acidIntrinsically labelled (57Fe) or non labelled X.gideon flour mixed with butter and sugar meal with FeSO4 (extrinsic label, isotopic iron 58) and ascorbic acid |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female, 18 to 45 years old
- Normal Body Mass Index (18.5 - 25 kg/m2)
- Body weight ≤ 55 kg
- Non-anemic (hemoglobin (Hb) >12.0 g/dL)
- Serum Ferritin < 25 μg/L;
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Bread and butterA bread with butter meal without insect biomass with FeSO4 (isotopic iron 54) | Other | Bread and butter |
| X.gideonIntrinsically labelled (57Fe) or non labelled X.gideon flour mixed with butter and sugar meal with FeSO4 (extrinsic label, isotopic iron 58) | Other | X.gideon |
| X.gideon with ascorbic acidIntrinsically labelled (57Fe) or non labelled X.gideon flour mixed with butter and sugar meal with FeSO4 (extrinsic label, isotopic iron 58) and ascorbic acid | Other | X.gideon with ascorbic acid |
Primary outcome
Fractional Iron absorption
Time frame: 30th day of the study
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.
6 secondary outcomes
Hemoglobin (Hb)
Time frame: screening (-1), day 16th and day 30th of the study
Plasma ferritin (PF)
Time frame: screening (-1), day 16th and day 30th of the study
C-Reactive Protein (CRP)
Time frame: screening (-1), day 16th and day 30th of the study
Soluble transferring receptor (sTfR)
Time frame: screening (-1), day 16th and day 30th of the study
Body iron stores (BIS)
Time frame: screening (-1), day 16th and day 30th of the study
Alpha 1 acid glycoprotein (AGP)
Time frame: screening (-1), day 16th and day 30th of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nikolin Hilaj, MSc principal investigator
Laboratory of Human Nutrition ETH Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bread and butter, X.gideon and X.gideon with ascorbic acid in people with Iron-deficiency, run by Swiss Federal Institute of Technology 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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional Iron absorption (time frame: 30th 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 10 Jun 2022.