- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06822062
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Diego Moretti, Prof.
- Phone Number: +41 44 512 09 20
- Email: diego.moretti@ffhs.ch
Study Locations
-
-
ZH
-
Zürich, ZH, Switzerland, 8005
- Recruiting
- ETH Zurich
-
Contact:
- Phone Number: 0445120920
- Email: diego.moretti@ffhs.ch
-
Contact:
- Diego Moretti
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
Collaborators
Investigators
- Principal Investigator: Diego Moretti, Prof., Fernfachhochschule Schweiz
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INSECTE_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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