Malnutrition; ProteinNCT05885191
True Ileal Amino Acid Digestibility of Tenebrio Molitor Larvae in Women
A study testing 2H intrinsically-labeled T.molitor with 13-C labeled amino acid mixture in people with Malnutrition; Protein, run by Diego Moretti at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malnutrition; Protein
- What is being tested?
- 2H intrinsically-labeled T.molitor with 13-C labeled amino acid mixture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Aug 2023to 16 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Malnutrition; Protein
- Being tested
- 2H intrinsically-labeled T.molitor with 13-C labeled amino acid mixture
- Keywords
- edible insects, Tenebrio molitor, digestibility, protein quality, amino acids
- Medical subject headings
- Kwashiorkor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2H intrinsically-labeled T.molitor with 13-C labeled amino acid mixtureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: 2H intrinsically-labeled T.molitor with 13-C labeled amino acid mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1st day
Secondary outcomes (3)
Hemoglobin (Hb)
Iron status marker
Measured: -14 days
C-Reactive Protein (CRP)
inflammation status
Measured: -14 days
Appearance of 13CO2 enrichment in breath
Rate of amino acid oxidation
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start30 Aug 2023
- Primary completion30 Nov 2023
- Study completion16 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition; ProteinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diego Moretti
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Distance University of Applied Sciences, Swiss Federal Institute of Technology, St. John's Research Institute, Wageningen University and Research
- Responsible party
- Sponsor-investigator, Diego Moretti, Swiss Distance University of Applied Sciences
- Investigators
- Diego Moretti, Prof. Dr., Principal investigator, Swiss Distance University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885191
- Sponsor's protocol ID
- TmD01
- Status last verified
- Apr 2024
- First submitted
- 23 May 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- True Ileal Amino Acid Digestibility of Tenebrio Molitor Larvae Determined by Dual Stable Isotope Tracer Method in Young Women
- ClinicalTrials.gov ID
- NCT05885191
- Acronym / sponsor ID
- TmD01
- Conditions
- Malnutrition; Protein
- Keywords
- edible insects, Tenebrio molitor, digestibility, protein quality, amino acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Diego MorettiUniversity, hospital or other
- Collaborators
- Swiss Distance University of Applied Sciences, Swiss Federal Institute of Technology, St. John's Research Institute, Wageningen University and Research
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2H intrinsically-labeled T.molitor | Experimental | Other: 2H intrinsically-labeled T.molitor with 13-C labeled amino acid mixture1 portion of bread and vegetable soup prepared with dried 2H intrinsically labeled T.molitor and 13C labeled reference amino acid mixture |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2H intrinsically-labeled T.molitor with 13-C labeled amino acid mixtureTest 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. | Other | 2H intrinsically-labeled T.molitor |
Primary outcome
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
3 secondary outcomes
Hemoglobin (Hb)
Time frame: -14 days
C-Reactive Protein (CRP)
Time frame: -14 days
Appearance of 13CO2 enrichment in breath
Time frame: 1st day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Moretti, Prof. Dr. principal investigator
Swiss Distance University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2H intrinsically-labeled T.molitor with 13-C labeled amino acid mixture in people with Malnutrition; Protein, run by Diego Moretti at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
True ileal amino acid digestibility (time frame: 1st day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.