True Ileal Amino Acid Digestibility of Tenebrio Molitor Larvae in Women

NCT ID: NCT05885191

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2024-04-16

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss Distance University of Applied Sciences

OTHER

Sponsor Role: collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role: collaborator

St. John's Research Institute

OTHER

Sponsor Role: collaborator

Wageningen University and Research

OTHER

Sponsor Role: collaborator

Diego Moretti

OTHER

Sponsor Role: lead

Responsible Party

Diego Moretti

Head of Nutrition Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Diego Moretti, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Swiss Distance University of Applied Sciences

Locations

ETH Zurich, Laboratory of Human Nutrition

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

TmD01

Identifier Type: -

Identifier Source: org_study_id