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True Ileal Amino Acid Digestibility of Tenebrio Molitor Larvae in Women

Primary Purpose

Malnutrition; Protein

Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
2H intrinsically-labeled T.molitor with 13-C labeled amino acid mixture
Sponsored by
Diego Moretti
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Malnutrition; Protein focused on measuring edible insects, Tenebrio molitor, digestibility, protein quality, amino acids

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • ETH Zurich, Laboratory of Human Nutrition

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

2H intrinsically-labeled T.molitor

Arm Description

1 portion of bread and vegetable soup prepared with dried 2H intrinsically labeled T.molitor and 13C labeled reference amino acid mixture

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hemoglobin (Hb)
Iron status marker
C-Reactive Protein (CRP)
inflammation status
Appearance of 13CO2 enrichment in breath
Rate of amino acid oxidation

Full Information

First Posted
May 23, 2023
Last Updated
October 24, 2023
Sponsor
Diego Moretti
Collaborators
Swiss Distance University of Applied Sciences, Swiss Federal Institute of Technology, St. John's Research Institute, Wageningen University and Research
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1. Study Identification

Unique Protocol Identification Number
NCT05885191
Brief Title
True Ileal Amino Acid Digestibility of Tenebrio Molitor Larvae in Women
Official Title
True Ileal Amino Acid Digestibility of Tenebrio Molitor Larvae Determined by Dual Stable Isotope Tracer Method in Young Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Diego Moretti
Collaborators
Swiss Distance University of Applied Sciences, Swiss Federal Institute of Technology, St. John's Research Institute, Wageningen University and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition; Protein
Keywords
edible insects, Tenebrio molitor, digestibility, protein quality, amino acids

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2H intrinsically-labeled T.molitor
Arm Type
Experimental
Arm Description
1 portion of bread and vegetable soup prepared with dried 2H intrinsically labeled T.molitor and 13C labeled reference amino acid mixture
Intervention Type
Other
Intervention Name(s)
2H intrinsically-labeled T.molitor with 13-C labeled amino acid mixture
Intervention Description
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.
Primary Outcome Measure Information:
Title
True ileal amino acid digestibility
Description
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
Time Frame
1st day
Secondary Outcome Measure Information:
Title
Hemoglobin (Hb)
Description
Iron status marker
Time Frame
-14 days
Title
C-Reactive Protein (CRP)
Description
inflammation status
Time Frame
-14 days
Title
Appearance of 13CO2 enrichment in breath
Description
Rate of amino acid oxidation
Time Frame
1st day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diego Moretti, Prof. Dr.
Organizational Affiliation
Swiss Distance University of Applied Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
ETH Zurich, Laboratory of Human Nutrition
City
Zürich
ZIP/Postal Code
8092
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

True Ileal Amino Acid Digestibility of Tenebrio Molitor Larvae in Women

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