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NCT Number: NCT05885191

True Ileal Amino Acid Digestibility of Tenebrio Molitor Larvae in 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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ETH Zurich, Laboratory of Human Nutrition

Zurich, 8092, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. True ileal amino acid digestibility

    Time frame: 1st day

    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 outcomes

  1. Hemoglobin (Hb)

    Time frame: -14 days

    Iron status marker

  2. C-Reactive Protein (CRP)

    Time frame: -14 days

    inflammation status

  3. Appearance of 13CO2 enrichment in breath

    Time frame: 1st day

    Rate of amino acid oxidation

Sponsors and collaborators

Lead sponsor

Diego Moretti

Other

Collaborators

  • St. John's Research Institute
  • Swiss Distance University of Applied Sciences
  • Swiss Federal Institute of Technology
  • Wageningen University and Research

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jun 1, 2023
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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