True Ileal Amino Acid Digestibility of Tenebrio Molitor Larvae in Women

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

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition; Protein
• Intervention / Treatment: Other: 2H intrinsically-labeled T.molitor with 13-C labeled amino acid mixture

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8092
    • ETH Zurich, Laboratory of Human Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2H intrinsically-labeled T.molitor; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Diego Moretti
• Collaborators: Swiss Federal Institute of Technology; Wageningen University and Research; St. John's Research Institute; Swiss Distance University of Applied Sciences
• Investigators: Principal Investigator: Diego Moretti, Prof. Dr., Swiss Distance University of Applied Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): April 16, 2024

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: protein quality; amino acids; digestibility; Tenebrio molitor; edible insects
• Additional Relevant MeSH Terms: Nutrition Disorders; Severe Acute Malnutrition; Malnutrition; Kwashiorkor
• Other Study ID Numbers: TmD01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No