True Ileal Amino Acid Digestibility of Tenebrio Molitor Larvae in Women

Study Overview
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Brief Summary
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Dietary protein intake of adequate quality is essential for human health. Traditional animal source foods play a key role in providing high quality protein but are associated with a high burden on the environment. Therefore, viable alternative protein sources are needed to be able to meet human nutritional needs for the rapidly increasing world population, while keeping food production within the planetary boundaries. T. molitor (Yellow Mealworm larvae) is a sustainably produced and commercially available edible insect, which contains a high quantity of protein with a favorable amino acid profile. Protein quality evaluation considers the amino acid composition as well as the ileal digestibility of the food's individual amino acids, to assess if human dietary requirements for essential amino acids can be met by the protein source. The present study will measure the digestibility of essential amino acids from T. molitor with a minimally invasive dual stable isotope tracer method that follows a plateau-fed test meal protocol. T. molitor will be intrinsically labelled with the stable isotope deuterium (2H), which will be given along with a reference amino acid mixture of known digestibility, labelled with the stable isotope carbon-13 (13C). Based on the results from the present study, protein quality of T. molitor as a protein source for human nutrition can be assessed, allowing a direct comparison of this novel protein source to other protein sources, such as meat and legumes.

Official Title
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True Ileal Amino Acid Digestibility of Tenebrio Molitor Larvae Determined by Dual Stable Isotope Tracer Method in Young Women

Conditions
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Malnutrition; Protein

Intervention / Treatment
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* Other: 2H intrinsically-labeled T.molitor with 13-C labeled amino acid mixture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female aged between 18-45 years Normal BMI (18.5 - 25 kg/m2) Body weight < 60 kg Signed informed consent Able to communicate and comprehend English Are open-minded towards consuming insect-based meals Exclusion Criteria: Anaemic (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 Chronic medication intake (except for oral contraceptives) Daily exercise routine of high intensity Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months Participation in any clinical study within the last 30 days Food allergies, especially hypersensitivity to crustacea, dust mites, sea food, gluten, milk, or eggs History of serious illness or infection within 3 months of the study Cigarette smoking (> 1 cigarette per day) Difficulties with blood or breath sampling Participants who cannot be expected to comply with study protocol (e.g., not available for the full 8.5 hours of the study day or unable to follow fasting period) Inability to understand the information sheet and the informed consent form due to cognitive or language reasons

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2H intrinsically-labeled T.molitor<br>1 portion of bread and vegetable soup prepared with dried 2H intrinsically labeled T.molitor and 13C labeled reference amino acid mixture | Other: 2H intrinsically-labeled T.molitor with 13-C labeled amino acid mixture<br>* Test meal with dried 2H intrinsically labeled T.molitor and 13C labeled reference amino acid mixture will be divided into 10 portions, which will be given hourly over the course of 7 hours. The first consumption will be the priming meal, comprised of 3 portions and will additionally contain 13C sodium bicarbonate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| True ileal amino acid digestibility | True ileal amino acid digestibility of intrinsically 2H labelled mealworm larvae (Tenebrio molitor) will be determined, relative to a simultaneously administered 13C labelled amino acids mixture, by measuring the plasma appearance of 13C and 2H isotopic enrichments of amino acids at plateau | 1st day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin (Hb) | Iron status marker | -14 days | 
| C-Reactive Protein (CRP) | inflammation status | -14 days | 
| Appearance of 13CO2 enrichment in breath | Rate of amino acid oxidation | 1st day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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edible insects, Tenebrio molitor, digestibility, protein quality, amino acids