Protein MalabsorptionNCT04866927
Bioavailability of Proteins From Plant Based Diets
An observational study of Protein Malabsorption and Nutritional Deficiency, run by International Atomic Energy Agency at 1 site in Morocco.
Trial summary
Proteins play an important role as structural and functional components for the human body and prevent stunting. Protein quality has a great importance in meeting the nutritional needs of populations across the world throughout the life course, particularly during pregnancy and early childhood. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Malabsorption, Nutritional Deficiency, Nutritional Stunting
- What is being tested?
- Use of stable isotopic dilution to assess protein digestibility from Faba bean and to evaluate amino acid bioavailability
- How many people
- 5 participants
- Where
- 1 siteMorocco
- Study dates
- 25 Nov 2019to 15 Feb 2020
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuals who fit in the inclusion criteria.
Who may be able to join
- Healthy, non-pregnant adults 18-65 years of age
- Not taking any medication, including NSAIDs Not taking antibiotics within 4 weeks of study BMI within 18-35 range Stable weight
Who cannot join
- Children and elderly (over 65)
- Pregnancy Diagnosed with non-communicable or communicable disease Being under restrictive diet Antibiotics within 4 weeks of study Medications within 4 weeks of study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Stable Isotopic Dilution to Assess Protein Digestibility From Fava Bean and to Evaluate Amino Acid Bioavailability
Proteins play an important role as structural and functional components for the human body and prevent stunting. Protein quality has a great importance in meeting the nutritional needs of populations across the world throughout the life course, particularly during pregnancy and early childhood. Dietary protein deficiency is mainly due to protein indigestibility limiting indispensable amino acids (IAAs) bioavailability. In Morocco, as it's the case in many developing countries, diet is mainly based on a large consumption of cereals, fruits, vegetables and pulses, and is generally low in meat, which is the main source of protein and IAA.
The general objective of this study is to evaluate the digestibility of Fava bean proteins and bioavailability of IAA using a dual-tracer method with stable isotopes.
Read the detailed description
This study aims to develop stable isotope labeled protein of bean cultures that could be used for other local common foods, to quantify dietary indispensable amino acids from beans made available to the body for optimal growth, development and function and to participate in the development of a simple method to assess protein quality in vulnerable populations.
The project is divided in two parts: the first part of harvesting and production of deuterium labeled fava beans. The optimization test done the first year has shown that the best protocol for labelling was a pulse with 25% D2O followed with subsequent labeling with 2.5% D2O during 20 days.
The second part is the intervention stuy that is going to be conducted on 6 healthy volunteers (3 males, 3 females). Each participant will receive a test meal containing 13C labelled spirulina, 2H labelled Fava bean and 13C phenylalanine. The test meal will be divided on 11 subdoses: 3 sub-doses will be administrated at T0 and 1 subdose will be administrated at 1, 2, 3, 4, 5, 6 and 7h. The remaining sub-dose will be kept for measurement of IAA in the test meal. After eating the test meal, blood, urine and breath samples will be collected from each participant at the baseline (T0) and after 5-6, 7h and 8h.
- Being tested
- Use of stable isotopic dilution to assess protein digestibility from Faba bean and to evaluate amino acid bioavailability
- Keywords
- Proteins, Digestibility, Bioavailability, Indispensable Amino Acids, Plant-based food, Plant diet, Nutrition, Food security, Fava Bean, Vegetal proteins
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of stable isotopic dilution to assess protein digestibility from Faba bean and to evaluate amino acid bioavailabilityDietary supplement
Each participant will receive a test meal containing 13C labelled spirulina, 2H labelled Fava bean and 13C phenylalanine. The test meal will be divided on 11 subdoses: 3 sub-doses will be administrated at T0 and 1 subdose will be administrated at 1, 2, 3, 4, 5, 6 and 7h. The remaining sub-dose will be kept for measurement of IAA in the test meal. After eating the test meal, blood, urine and breath samples will be collected from each participant at the baseline (T0) and after 5-6, 7h and 8h.
| Study group | Role | What they receive |
|---|---|---|
| Adults | Inclusion criteria: Healthy, non-pregnant women, adults aged 18-65 years, not taking any medication, including NSAIDs, not taking antibiotics within 4 weeks of study, BMI within 18-35 range.
Exclusion criteria: Children and elderly (over 65), pregnant women, individuals diagnosed with non-communicable or communicable disease, being under restrictive diet, antibiotics within 4 weeks of study, medications within 4 weeks of study. Receives: Dietary Supplement: Use of stable isotopic dilution to assess protein digestibility from Faba bean and to evaluate amino acid bioavailability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Amino Acid Digestibility
The digestibility of each IAA from the 13C-labeled spirulina protein and TCF is an IAA-specific term used to correct for loss of a 2H atom during transamination.
Measured: One year
DIAAS
The digestible indispensable amino acid score (DIAAS), representing the content of each IAA, along with the digestibility of each IAA, in relation to the human requirement pattern was also calculated.
Measured: One year
Secondary outcomes (1)
Scientific articles
Publication of scientific reports and peer-reviewed papers and conference presentations.
Measured: By the end of 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start25 Nov 2019
- Primary completion31 Dec 2019
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Protein MalabsorptionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Atomic Energy Agency
- Sponsor type
- Other government
- Collaborators
- AgroParisTech, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Centre National De L'énergie, Des Sciences Et Techniques Nucléaires
- Responsible party
- Principal investigator, Khayour Meriam, International Atomic Energy Agency
- Investigators
- Mohammed El Mzibri, Principal investigator, Head of the Division of Life Sciences - CNESTENHassan Aguenaou, Study director, Director of Nutrition RDC of Morocco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866927
- Sponsor's protocol ID
- E43031
- Status last verified
- Apr 2021
- First submitted
- 16 Apr 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Khayour M, Benmhimdane A, Calvez J, Saeid N, Khodorova N, Belghiti H, El Hamdouchi A, El Kari K, Owino V, Tome D, Aguenaou H, Mentag R, El Mzibri M, Gaudichon C. Indispensable Amino Acid Digestibility of Moroccan Fava Bean Using the Dual Isotope Method in Healthy Adults. J Nutr. 2023 Feb;153(2):451-458. doi: 10.1016/j.tjnut.2022.11.015. Epub 2022 Dec 24.
PubMed 36894238
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Stable Isotopic Dilution to Assess Protein Digestibility From Fava Bean and to Evaluate Amino Acid Bioavailability
- ClinicalTrials.gov ID
- NCT04866927
- Acronym / sponsor ID
- E43031
- Keywords
- Proteins, Digestibility, Bioavailability, Indispensable Amino Acids, Plant-based food, Plant diet, Nutrition, Food security
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- International Atomic Energy AgencyOther government
- Collaborators
- AgroParisTech, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Centre National De L'énergie, Des Sciences Et Techniques Nucléaires
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 30 Apr 2021 (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.
Proteins play an important role as structural and functional components for the human body and prevent stunting. Protein quality has a great importance in meeting the nutritional needs of populations across the world throughout the life course, particularly during pregnancy and early childhood. Dietary protein deficiency is mainly due to protein indigestibility limiting indispensable amino acids (IAAs) bioavailability. In Morocco, as it's the case in many developing countries, diet is mainly based on a large consumption of cereals, fruits, vegetables and pulses, and is generally low in meat, which is the main source of protein and IAA.
The general objective of this study is to evaluate the digestibility of Fava bean proteins and bioavailability of IAA using a dual-tracer method with stable isotopes.
Detailed description
This study aims to develop stable isotope labeled protein of bean cultures that could be used for other local common foods, to quantify dietary indispensable amino acids from beans made available to the body for optimal growth, development and function and to participate in the development of a simple method to assess protein quality in vulnerable populations.
The project is divided in two parts: the first part of harvesting and production of deuterium labeled fava beans. The optimization test done the first year has shown that the best protocol for labelling was a pulse with 25% D2O followed with subsequent labeling with 2.5% D2O during 20 days.
The second part is the intervention stuy that is going to be conducted on 6 healthy volunteers (3 males, 3 females). Each participant will receive a test meal containing 13C labelled spirulina, 2H labelled Fava bean and 13C phenylalanine. The test meal will be divided on 11 subdoses: 3 sub-doses will be administrated at T0 and 1 subdose will be administrated at 1, 2, 3, 4, 5, 6 and 7h. The remaining sub-dose will be kept for measurement of IAA in the test meal. After eating the test meal, blood, urine and breath samples will be collected from each participant at the baseline (T0) and after 5-6, 7h and 8h.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults | – | Dietary Supplement: Use of stable isotopic dilution to assess protein digestibility from Faba bean and to evaluate amino acid bioavailabilityInclusion criteria: Healthy, non-pregnant women, adults aged 18-65 years, not taking any medication, including NSAIDs, not taking antibiotics within 4 weeks of study, BMI within 18-35 range. Exclusion criteria: Children and elderly (over 65), pregnant women, individuals diagnosed with non-communicable or communicable disease, being under restrictive diet, antibiotics within 4 weeks of study, medications within 4 weeks of study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals who fit in the inclusion criteria.
Key inclusion criteria (2 listed)
- Healthy, non-pregnant adults 18-65 years of age
- Not taking any medication, including NSAIDs Not taking antibiotics within 4 weeks of study BMI within 18-35 range Stable weight
Key exclusion criteria (2 listed)
- Children and elderly (over 65)
- Pregnancy Diagnosed with non-communicable or communicable disease Being under restrictive diet Antibiotics within 4 weeks of study Medications within 4 weeks of study
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 |
|---|---|---|
| Use of stable isotopic dilution to assess protein digestibility from Faba bean and to evaluate amino acid bioavailabilityEach participant will receive a test meal containing 13C labelled spirulina, 2H labelled Fava bean and 13C phenylalanine. The test meal will be divided on 11 subdoses: 3 sub-doses will be administrated at T0 and 1 subdose will be administrated at 1, 2, 3, 4, 5, 6 and 7h. The remaining sub-dose will be kept for measurement of IAA in the test meal. After eating the test meal, blood, urine and breath samples will be collected from each participant at the baseline (T0) and after 5-6, 7h and 8h. | Dietary supplement | Adults |
Primary outcome
Relative Amino Acid Digestibility
Time frame: One year
The digestibility of each IAA from the 13C-labeled spirulina protein and TCF is an IAA-specific term used to correct for loss of a 2H atom during transamination.
DIAAS
Time frame: One year
The digestible indispensable amino acid score (DIAAS), representing the content of each IAA, along with the digestibility of each IAA, in relation to the human requirement pattern was also calculated.
1 secondary outcome
Scientific articles
Time frame: By the end of 2020
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 30 Apr 2021.
- Derived from this study: PubMed 36894238Khayour M, Benmhimdane A, Calvez J, Saeid N, Khodorova N, Belghiti H, El Hamdouchi A, El Kari K, Owino V, Tome D, Aguenaou H, Mentag R, El Mzibri M, Gaudichon C. Indispensable Amino Acid Digestibility of Moroccan Fava Bean Using the Dual Isotope Method in Healthy Adults. J Nutr. 2023 Feb;153(2):451-458. doi: 10.1016/j.tjnut.2022.11.015. Epub 2022 Dec 24.
- Individual participant dataSharing planned: Undecided
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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.
Mohammed El Mzibri principal investigator
Head of the Division of Life Sciences - CNESTEN
Hassan Aguenaou study director
Director of Nutrition RDC of Morocco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Protein Malabsorption and Nutritional Deficiency, run by International Atomic Energy Agency at 1 site in Morocco.
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 2 inclusion and 2 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 30 Apr 2021. 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 Morocco. 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?
Relative Amino Acid Digestibility (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04866927, which also lists 1 linked publication.
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 30 Apr 2021.