HealthyVALDIMNCT05426551
Validation of the Dual-isotope Method for Measuring Ileal Protein Digestibility
A study testing Dual isotope method in people with Healthy, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial summary
The dual isotope method has been recently developed and used to evaluate indispensable amino acid (IAA) digestibility of various protein food such as legumes, eggs and chicken meat in healthy adults and children. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dual isotope method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 23 Oct 2022to 30 Dec 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18<BMI<30
- Healthy
- Insured under the French social security system
- For women: use of birth control
- Signed informed consent
Who cannot join
- Any dietary allergy
- Latex allergy
- Positive serology to HIV, hepatite C virus antibody, hepatite B virus surface antigen and core antibodies
- Gluten intolerance
- Anemia
- Use of drugs
Show all 13Show fewer
- High consumption of alcohol
- Hypertension, diabetes, digestive disease, hepatic or renal disease, severe cardiac disease
- Pregnancy
- High sport practicing (>7h/wk)
- Blood donation in the 3 months prior to the study
- Participation in a clinical study in the 3 months prior to the study
- No signed informed consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre de Recherche sur Volontaires (CRV) de l'hôpital Avicenne
Bobigny, 93000
Juliane Calvez, PhD, juliane.calvez@agroparistech.fr
About this study
The dual isotope method has been recently developed and used to evaluate indispensable amino acid (IAA) digestibility of various protein food such as legumes, eggs and chicken meat in healthy adults and children. The dual isotope method is an indirect method based on the measurement in plasma of absorbed IAA from a deuterium (2H) intrinsically labeled test protein compared against the same IAA of a carbon 13 (13C) intrinsically labeled standard protein of known digestibility or crystalline amino acids (AA) of theoretical 100% digestibility. However, digestibility data estimated with the dual isotope method have not been directly compared with ileal IAA digestibility directly determined through ileal digesta sampling. The goal of this study is to assess the IAA digestibility of intrinsically 2H-hen's egg in healthy volunteers using both indirect and direct methods.
Read the detailed description
The test meal will consist of 60 g of lyophilized whole egg powder which contains 30 g of 2H-egg protein and 800 mg [U-13C]-spirulina or 400 mg of 13C free AA mixture, mixed with water and cooked as an omelet. The 2H-egg powder has been produced by our collaborators of the St John's Research Institute in Bangalore (India). Celite (acid insoluble ash, Advanced Minerals Corporation) will be added to the meal as an indigestible marker to check the recovery of the meal in effluents. The test-meal will be given as a bolus or in a plateau feeding (repeated mini-meals) depending of the groups of subjects. 600 g of 2H-labeled lyophilized eggs will be obtained from layer hens administered a uniformly 2H-labeled AA mix orally for 60 d with their daily feed. Microbiological analyses will be performed to ensure their safety for human consumption.
18 volunteers will be included at the end of the study and tested at the Human Nutrition Research Centre of Avicenne Hospital (France). The main inclusion criteria are men and women, 18 to 45 year-old, body mass index (BMI) 18 to 30 kg/m2. The main exclusion criteria are any digestive or hepatic pathology, allergy against eggs, allergy against latex, pregnant women. Due to the invasive procedure of intubation, the investigators plan to recruit 30 volunteers to accommodate for the usual 40% dropouts.
The subjects will be divided in 3 groups of n = 6:
- Bolus-spi, n = 6, the volunteers will consume the test-meal as a bolus in one time at t = 0, with 13C-spirulina as the reference protein
- Plateau-spi, n = 6, the volunteers will consume the test-meal in a plateau feeding protocol, with 13C-spirulina as the reference protein
- Plateau-AA, n = 6, the volunteers will consume the test-meal in a plateau feeding protocol, with 13C-free AA mixture as the reference "protein"
One week before the experiment, the volunteers will follow a standard diet adapted to their body weight to control their protein intake (1.3 g protein/kg body weight).
The volunteers will arrive at the Human Nutrition Research Centre of Avicenne Hospital on the morning before the day of the experiment. They will be equipped with a triple lumen intestinal tube that will be allowed to progress through the intestinal tract for 24 h. One of the lumen is radio opaque and serves to perfuse a non-absorbable maker in the intestine (slow marker method). The second lumen is dedicated to inflate a weighted balloon that facilitate the migration of the tube. The third lumen is dedicated to the continuous aspiration of the effluents, 15 cm below the perfusion site. The measurement of the non-absorbable marker in the effluents allows the determination of the effluent flow rate.
On the day of the experiment, the position of the tube will be checked by radiography to verify its location at the terminal ileum. A catheter will be inserted in the forearm vein for blood sampling. The perfusion of the non-absorbable marker, polyethylene glycol (PEG) 4000 (20 g/l), will start at a flow rate of 1 ml/min. The intestinal flow and the basal ileal sample will be collected during 30 min. Basal plasma and urine sample will be collected.
At t = 0, the volunteers of the group "Bolus-spi" will consume all the test-meal in less the 20 min. For the volunteers of the groups "Plateau-spi" and "Plateau-AA", the test-meal will be divided into 22 equal portions and they will consume the first meal as a priming dose of 6 mini-portions. Then, they will consume single mini-portions every 30 min for 7.5 h. One portion will be dedicated to meal analyses. Until t = 8, intestinal content will be continuously collected by aspiration and pooled every 30 min. Blood will be sampled hourly during 4 h and every 30 min from t = 5 to t = 8. Urine will be collected every 2 h until t=8 (total volume of urine output will be noted at each time point for proportional pooling). Breath samples will be collected every 30 min. Carbon dioxide output (VCO2) will be evaluated hourly during 10 min by indirect calorimetry (Canopy). Urine sample will be collected at the start of the experiment and during the study protocol. Fecal samples will be collected before the start of the experiment and within the next 24 h. The naso-ileal tube will be removed after the last collection of effluent at t = 8.The naso-ileal tube will be removed after the last collection of effluent at t=8.
The following analyses will be performed:
- Concentration of PEG-4000 by turbidimetric method in digesta samples
- Total hydrogen content and 2H enrichment in meals and digesta samples by isotope-ratio mass spectrometry (IRMS) coupled to pyrolysis analyzer
- Total carbon content and 13C enrichment in meals and digesta samples by Elemental analyzer (EA) coupled to IRMS
- AA concentration in meals and digesta samples by Ultra High Performance Liquid Chromatography (UHPLC)
- 13C-AA and 2H-AA enrichment plasma and meal samples by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
- 13C-AA and 2H-AA enrichment in digesta and meal samples by gas chromatography-combustion-isotope ratio mass spectrometry (GC-C-IRMS)
- Celite content in pooled (0-8 h) digesta samples
- 13CO2 in breath sample by Multiflow-IRMS
- Amino-acidome and peptidome of digesta, plasma, urine, and fecal samples
Part of the analyses (13C-AA and 2H-AA enrichment plasma and meal by LC-MS/MS, -omic analyses) will be done by our collaborators of the St John's Research Institute in Bangalore (India).
- Conditions
- Healthy
- Being tested
- Dual isotope method
- Keywords
- amino acid digestibility, dual isotope method, labelled protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual isotope methodOther
The digestibility of amino acids will be determined within each arm by the collection of ileal digesta owing to naso-ileal intubation device and by plasma samples with the dual isotope method.
| Study group | Role | What they receive |
|---|---|---|
| Bolus-spi | Experimental | The volunteers will consume the test-meal as a bolus in one time at t = 0, with 13C-spirulina as the reference protein Receives: Other: Dual isotope method |
| Plateau-spi | Experimental | The volunteers will consume the test-meal in a plateau feeding protocol, with 13C-spirulina as the reference protein Receives: Other: Dual isotope method |
| Plateau-AA | Experimental | The volunteers will consume the test-meal in a plateau feeding protocol, with 13C-free AA mixture as the reference "protein" Receives: Other: Dual isotope method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real ileal amino acid digestibility
The measurements of amino acid concentration (mmol) and their individual 2H enrichment (atom %) allow the determination of dietary amino acids remaining in the lumen.
Dietary amino acids that are recovered in the ileal samples are then considered as non absorbed and expressed as % of amino acid ingested, it allows the calculation of real ileal amino acid digestibility (100 - dietary amino acid not absorbed)
Measured: -30 minute to 8 hours after the first meal
Indirect amino acid digestibility
The individual amino acid 2H enrichment (atom %) and 13C enrichment (atom %) in the meal and in the plasma from 5 h to 8 h or 0 h to 8 h after the first meal (depending of the group) will be evaluated to calculate their ratio:
Ratio meal AAi = 2H meal AAi / 13C meal AAi Ratio plasma AAi = 2H plasma AAi / 13C plasma AAi
The ratio of the meal and plasma ratios will be corrected by the known digestibility of spirulina amino acid or free amino acid (in %, depending of the group) to determine the indirect amino acid digestibility of lyophilized egg protein with the following formula:
Indirect ileal amino acid digestibility (%) = AAi ileal digestibility spirulina or free AA mix (%) x Ratio plasma AAi / Ratio meal AAi
Measured: -30 minute to 8 hours after the first meal
Secondary outcomes (3)
Urinary, fecal and plasma individual amino acid concentration in response to protein ingestion
Determination of amino acids concentrations (in mmol) in plasma, urinary and fecal samples and bioinformatic analysis, before and after ingestion of protein meal for characterisation of non- or minimally-invasive markers of digestibility
Measured: -30 minute to 8 hours after the first meal
Plasma, urinary and fecal peptidome in response to protein ingestion
Sequencing of peptides in plasma, urinary and fecal samples and bioinformatic analysis, before and after ingestion of protein meal for characterisation of non- or minimally-invasive markers of digestibility
Measured: -30 minute to 8 hours after the first meal
Gut microbiota in response to protein ingestion
Microbial DNA sequencing of fecal samples before and after ingestion of protein meal
Measured: Before and 24 hours after meal intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start23 Oct 2022
- Primary completion30 May 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- St. John's Research Institute
- Responsible party
- Principal investigator, Robert Benamouzig, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426551
- Sponsor's protocol ID
- VALDIM
- Acronym
- VALDIM
- Status last verified
- Mar 2024
- First submitted
- 31 May 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Dual-isotope Method for Measuring Ileal Protein Digestibility
- ClinicalTrials.gov ID
- NCT05426551
- Acronym / sponsor ID
- VALDIM / VALDIM
- Conditions
- Healthy
- Keywords
- amino acid digestibility, dual isotope method, labelled protein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- St. John's Research Institute
- Study start
- 23 Oct 2022 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 22 Jun 2022 (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.
The dual isotope method has been recently developed and used to evaluate indispensable amino acid (IAA) digestibility of various protein food such as legumes, eggs and chicken meat in healthy adults and children. The dual isotope method is an indirect method based on the measurement in plasma of absorbed IAA from a deuterium (2H) intrinsically labeled test protein compared against the same IAA of a carbon 13 (13C) intrinsically labeled standard protein of known digestibility or crystalline amino acids (AA) of theoretical 100% digestibility. However, digestibility data estimated with the dual isotope method have not been directly compared with ileal IAA digestibility directly determined through ileal digesta sampling. The goal of this study is to assess the IAA digestibility of intrinsically 2H-hen's egg in healthy volunteers using both indirect and direct methods.
Detailed description
The test meal will consist of 60 g of lyophilized whole egg powder which contains 30 g of 2H-egg protein and 800 mg [U-13C]-spirulina or 400 mg of 13C free AA mixture, mixed with water and cooked as an omelet. The 2H-egg powder has been produced by our collaborators of the St John's Research Institute in Bangalore (India). Celite (acid insoluble ash, Advanced Minerals Corporation) will be added to the meal as an indigestible marker to check the recovery of the meal in effluents. The test-meal will be given as a bolus or in a plateau feeding (repeated mini-meals) depending of the groups of subjects. 600 g of 2H-labeled lyophilized eggs will be obtained from layer hens administered a uniformly 2H-labeled AA mix orally for 60 d with their daily feed. Microbiological analyses will be performed to ensure their safety for human consumption.
18 volunteers will be included at the end of the study and tested at the Human Nutrition Research Centre of Avicenne Hospital (France). The main inclusion criteria are men and women, 18 to 45 year-old, body mass index (BMI) 18 to 30 kg/m2. The main exclusion criteria are any digestive or hepatic pathology, allergy against eggs, allergy against latex, pregnant women. Due to the invasive procedure of intubation, the investigators plan to recruit 30 volunteers to accommodate for the usual 40% dropouts.
The subjects will be divided in 3 groups of n = 6:
- Bolus-spi, n = 6, the volunteers will consume the test-meal as a bolus in one time at t = 0, with 13C-spirulina as the reference protein
- Plateau-spi, n = 6, the volunteers will consume the test-meal in a plateau feeding protocol, with 13C-spirulina as the reference protein
- Plateau-AA, n = 6, the volunteers will consume the test-meal in a plateau feeding protocol, with 13C-free AA mixture as the reference "protein"
One week before the experiment, the volunteers will follow a standard diet adapted to their body weight to control their protein intake (1.3 g protein/kg body weight).
The volunteers will arrive at the Human Nutrition Research Centre of Avicenne Hospital on the morning before the day of the experiment. They will be equipped with a triple lumen intestinal tube that will be allowed to progress through the intestinal tract for 24 h. One of the lumen is radio opaque and serves to perfuse a non-absorbable maker in the intestine (slow marker method). The second lumen is dedicated to inflate a weighted balloon that facilitate the migration of the tube. The third lumen is dedicated to the continuous aspiration of the effluents, 15 cm below the perfusion site. The measurement of the non-absorbable marker in the effluents allows the determination of the effluent flow rate.
On the day of the experiment, the position of the tube will be checked by radiography to verify its location at the terminal ileum. A catheter will be inserted in the forearm vein for blood sampling. The perfusion of the non-absorbable marker, polyethylene glycol (PEG) 4000 (20 g/l), will start at a flow rate of 1 ml/min. The intestinal flow and the basal ileal sample will be collected during 30 min. Basal plasma and urine sample will be collected.
At t = 0, the volunteers of the group "Bolus-spi" will consume all the test-meal in less the 20 min. For the volunteers of the groups "Plateau-spi" and "Plateau-AA", the test-meal will be divided into 22 equal portions and they will consume the first meal as a priming dose of 6 mini-portions. Then, they will consume single mini-portions every 30 min for 7.5 h. One portion will be dedicated to meal analyses. Until t = 8, intestinal content will be continuously collected by aspiration and pooled every 30 min. Blood will be sampled hourly during 4 h and every 30 min from t = 5 to t = 8. Urine will be collected every 2 h until t=8 (total volume of urine output will be noted at each time point for proportional pooling). Breath samples will be collected every 30 min. Carbon dioxide output (VCO2) will be evaluated hourly during 10 min by indirect calorimetry (Canopy). Urine sample will be collected at the start of the experiment and during the study protocol. Fecal samples will be collected before the start of the experiment and within the next 24 h. The naso-ileal tube will be removed after the last collection of effluent at t = 8.The naso-ileal tube will be removed after the last collection of effluent at t=8.
The following analyses will be performed:
- Concentration of PEG-4000 by turbidimetric method in digesta samples
- Total hydrogen content and 2H enrichment in meals and digesta samples by isotope-ratio mass spectrometry (IRMS) coupled to pyrolysis analyzer
- Total carbon content and 13C enrichment in meals and digesta samples by Elemental analyzer (EA) coupled to IRMS
- AA concentration in meals and digesta samples by Ultra High Performance Liquid Chromatography (UHPLC)
- 13C-AA and 2H-AA enrichment plasma and meal samples by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS)
- 13C-AA and 2H-AA enrichment in digesta and meal samples by gas chromatography-combustion-isotope ratio mass spectrometry (GC-C-IRMS)
- Celite content in pooled (0-8 h) digesta samples
- 13CO2 in breath sample by Multiflow-IRMS
- Amino-acidome and peptidome of digesta, plasma, urine, and fecal samples
Part of the analyses (13C-AA and 2H-AA enrichment plasma and meal by LC-MS/MS, -omic analyses) will be done by our collaborators of the St John's Research Institute in Bangalore (India).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bolus-spi | Experimental | Other: Dual isotope methodThe volunteers will consume the test-meal as a bolus in one time at t = 0, with 13C-spirulina as the reference protein |
| Plateau-spi | Experimental | Other: Dual isotope methodThe volunteers will consume the test-meal in a plateau feeding protocol, with 13C-spirulina as the reference protein |
| Plateau-AA | Experimental | Other: Dual isotope methodThe volunteers will consume the test-meal in a plateau feeding protocol, with 13C-free AA mixture as the reference "protein" |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18<BMI<30
- Healthy
- Insured under the French social security system
- For women: use of birth control
- Signed informed consent
Key exclusion criteria (13 listed)
- Any dietary allergy
- Latex allergy
- Positive serology to HIV, hepatite C virus antibody, hepatite B virus surface antigen and core antibodies
- Gluten intolerance
- Anemia
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 |
|---|---|---|
| Dual isotope methodThe digestibility of amino acids will be determined within each arm by the collection of ileal digesta owing to naso-ileal intubation device and by plasma samples with the dual isotope method. | Other | Bolus-spi, Plateau-AA, Plateau-spi |
Primary outcome
Real ileal amino acid digestibility
Time frame: -30 minute to 8 hours after the first meal
The measurements of amino acid concentration (mmol) and their individual 2H enrichment (atom %) allow the determination of dietary amino acids remaining in the lumen. Dietary amino acids that are recovered in the ileal samples are then considered as non absorbed and expressed as % of amino acid ingested, it allows the calculation of real ileal amino acid digestibility (100 - dietary amino acid not absorbed)
Indirect amino acid digestibility
Time frame: -30 minute to 8 hours after the first meal
The individual amino acid 2H enrichment (atom %) and 13C enrichment (atom %) in the meal and in the plasma from 5 h to 8 h or 0 h to 8 h after the first meal (depending of the group) will be evaluated to calculate their ratio: Ratio meal AAi = 2H meal AAi / 13C meal AAi Ratio plasma AAi = 2H plasma AAi / 13C plasma AAi The ratio of the meal and plasma ratios will be corrected by the known digestibility of spirulina amino acid or free amino acid (in %, depending of the group) to determine the indirect amino acid digestibility of lyophilized egg protein with the following formula: Indirect ileal amino acid digestibility (%) = AAi ileal digestibility spirulina or free AA mix (%) x Ratio plasma AAi / Ratio meal AAi
3 secondary outcomes
Urinary, fecal and plasma individual amino acid concentration in response to protein ingestion
Time frame: -30 minute to 8 hours after the first meal
Plasma, urinary and fecal peptidome in response to protein ingestion
Time frame: -30 minute to 8 hours after the first meal
Gut microbiota in response to protein ingestion
Time frame: Before and 24 hours after meal intake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual isotope method in people with Healthy, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 5 Mar 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliane Calvez, PhD (+33144088677, juliane.calvez@agroparistech.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real ileal amino acid digestibility (time frame: -30 minute to 8 hours after the first meal). 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?
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 5 Mar 2024.