Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05328141
Other study ID # Sust-iron-able2
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date May 20, 2022
Est. completion date July 30, 2022

Study information

Verified date June 2022
Source Swiss Federal Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 11
Est. completion date July 30, 2022
Est. primary completion date July 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Bread and butter
A bread with butter meal without insect biomass with FeSO4 (isotopic iron 54)
X.gideon
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 acid
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

Locations

Country Name City State
Switzerland ETH Zurich, Laboratory of Human Nutrition Zurich

Sponsors (2)

Lead Sponsor Collaborator
Swiss Federal Institute of Technology Zurich University of Applied Sciences

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30th day of the study
Secondary Hemoglobin (Hb) Iron status marker screening (-1), day 16th and day 30th of the study
Secondary Plasma ferritin (PF) Iron status marker screening (-1), day 16th and day 30th of the study
Secondary C-Reactive Protein (CRP) Inflammation status screening (-1), day 16th and day 30th of the study
Secondary Soluble transferring receptor (sTfR) Iron status marker screening (-1), day 16th and day 30th of the study
Secondary Body iron stores (BIS) Iron status marker screening (-1), day 16th and day 30th of the study
Secondary Alpha 1 acid glycoprotein (AGP) Inflammation marker screening (-1), day 16th and day 30th of the study
See also
  Status Clinical Trial Phase
Completed NCT04949165 - Bloodsafe Ghana- Iron and Nutritional Counseling Strategy Pilot Study N/A
Terminated NCT03218384 - Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency Phase 2
Active, not recruiting NCT03516734 - Iron-fortified Lentils to Improve Iron (Fe) Status in Bangladesh N/A
Completed NCT03572010 - Stable Iron Isotope Method in HIV+ and HIV- Children N/A
Active, not recruiting NCT03703726 - Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures. N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Not yet recruiting NCT05395468 - Diagnosis of Iron Deficiency by Artificial Intelligence Analysis of Eye Photography.
Withdrawn NCT03800446 - Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood N/A
Not yet recruiting NCT03353662 - Sub Regional Micronutrient Survey in Ethiopia
Completed NCT03819530 - Child of Urban Poverty Iron Project (CUPIP) - A Pilot Study N/A
Recruiting NCT04144790 - Impact of Iron Supplementation Treatment on Brain Iron Concentrations
Completed NCT03957057 - Intravenous Iron Carboxymaltose, Isomaltoside and Oral Iron Sulphate for Postpartum Anemia Phase 3
Completed NCT03642223 - Central and Peripheral Adiposity and Iron Absorption N/A
Not yet recruiting NCT05407987 - Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery) Phase 3
Withdrawn NCT03873584 - Improvement of Fatigue Symptoms in the Iron Deficiency Anemia With Iron Succinylate Therapy
Enrolling by invitation NCT03897673 - Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas N/A
Completed NCT04359368 - Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions
Active, not recruiting NCT04778072 - A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects N/A
Enrolling by invitation NCT05750940 - Oxidative Skeletal Muscle Metabolism in Chronic Heart Failure Patients With and Without Iron Deficiency
Recruiting NCT05126901 - Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years Phase 3