True Ileal Amino Acid Digestibility of Tenebrio Molitor Larvae in Women

NCT05885191 | Completed DMC

• 1 other identifier: TmD01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition; Protein

Keywords

edible insects; Tenebrio molitor; digestibility; protein quality; amino acids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hemoglobin (Hb)

  -14 days

• C-Reactive Protein (CRP)

  -14 days

• Appearance of 13CO2 enrichment in breath

  1st day

Study Arms (1)

2H intrinsically-labeled T.molitor

EXPERIMENTAL

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

Interventions

2H intrinsically-labeled T.molitor with 13-C labeled amino acid mixture OTHER

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.

2H intrinsically-labeled T.molitor

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diego Moretti: lead
• Swiss Distance University of Applied Sciences: collaborator
• Swiss Federal Institute of Technology: collaborator
• St. John's Research Institute: collaborator
• Wageningen University and Research: collaborator

Study Sites (1)

ETH Zurich, Laboratory of Human Nutrition

Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Kwashiorkor

Condition Hierarchy (Ancestors)

Severe Acute Malnutrition; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Diego Moretti, Prof. Dr.

  Swiss Distance University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Nutrition Research

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 1, 2023
• Study Start: August 30, 2023
• Primary Completion: November 30, 2023
• Study Completion: April 16, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)