Clinical trial NCT05328141: Measuring Dietary Iron Absorption From Edible Insects and Assessing the Effect of Chitin Content on Iron Bioavailability (Study 2)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Iron-deficiency
Keywords: edible insects
iron bioavailability
ascorbic acid
Xylotrupes gideon
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Zurich University of Applied Sciences
First posted: 2022-04-14
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Fractional Iron absorption
timeFrame: 30th day of the study
Secondary outcomes:
measure: Hemoglobin (Hb)
timeFrame: screening (-1), day 16th and day 30th of the study
measure: Plasma ferritin (PF)
timeFrame: screening (-1), day 16th and day 30th of the study
measure: C-Reactive Protein (CRP)
timeFrame: screening (-1), day 16th and day 30th of the study
measure: Soluble transferring receptor (sTfR)
timeFrame: screening (-1), day 16th and day 30th of the study
measure: Body iron stores (BIS)
timeFrame: screening (-1), day 16th and day 30th of the study
measure: Alpha 1 acid glycoprotein (AGP)
timeFrame: screening (-1), day 16th and day 30th of the study
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: ETH Zurich, Laboratory of Human Nutrition
Study officials:
affiliation: Laboratory of Human Nutrition ETH Zürich
name: Nikolin Hilaj, MSc
role: PRINCIPAL_INVESTIGATOR
References: