Amino AcidNCT03279211
Amino Acid Digestibility of Whey and Zein Proteins
A study testing Whey Protein Isolate 894 Fonterra, Zein Sigma-Aldrich W555025 and Protein-free test-meal in people with Amino Acid, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial summary
The main goal of the study is to determine true ileal amino acid digestibility of whey protein isolate (WPI) and zein proteins in healthy subjects equipped with naso-ileal tube. The endogenous losses of proteins and amino acids will be determined by collecting digesta samples after a protein-free diet in a third group… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Amino Acid
- What is being tested?
- Whey Protein Isolate 894 Fonterra, Zein Sigma-Aldrich W555025 and Protein-free test-meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2017to 20 Dec 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal body weight (18 < BMI < 30 kg.m-2)
- Women or men
- 18 - 65 y
- Healthy
- Insured under the French social security system
- Signed informed consent
- For women: use of birth control
Who cannot join
- People under trusteeship
- Latex, cow milk or corn allergy A
- HIV, hepatite C virus antibodies, hepatite B virus surface antigen and core antibodies positive
- Pregnant women
- Excessive alcohol drinking or drugs intake
- Hypertension, diabetes, digestive tract, liver or renal diseases, severe heart disease
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- High sport practicing (> 7h/week)
- 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.
About this study
Official title: True Ileal Amino Acid Digestibility of Whey and Zein Proteins in Healthy Volunteers With Naso-ileal Tubes
The main goal of the study is to determine true ileal amino acid digestibility of whey protein isolate (WPI) and zein proteins in healthy subjects equipped with naso-ileal tube. The endogenous losses of proteins and amino acids will be determined by collecting digesta samples after a protein-free diet in a third group of subjects.
Read the detailed description
True ileal amino acid digestibility of whey protein isolate (WPI) and zein proteins will be determined in healthy subjects. The endogenous losses of proteins and amino acids will be determined by collecting digesta samples after a protein-free test-meal in a different group of subjects.
24 volunteers will be included in the study (men and women; aged 18-65 y; BMI 18-30 kg/m2) and tested at AgroParisTech (Human Nutrition Research Centre of Avicenne Hospital). Due to the invasive procedure of intubation, each volunteer will test only one test-meal (n=8 / test-meal).
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 hospital the morning before the day of the experiment and will be equipped with a double lumen intestinal tube that will be allowed to progress through the intestinal tract for 24h. 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. A perfusion of the non-absorbable marker polyethylene glycol -4000 will start to estimate the intestinal flow and the basal ileal sample will be collected during 30 min. Basal plasma sample will be collected. Then, at t=0, the volunteer will drink the test-meal. Until t=9h, intestinal content will be continuously collected by aspiration and pooled every 30 minutes. Blood will be sampled every 30 minutes during 4h and hourly thereafter.
The test meal will consist of a protein-free biscuit (160 g) and a drink (500 ml) with the test protein as the sole source of protein or no protein for the protein-free group. Celite will be added to the protein-free biscuit and inulin labelled with carbon 13 will be added to the drink as indigestible markers of the meal to allow correction for incomplete collection of digesta. The test proteins will be WPI or zein.
The total nitrogen will be measured in meal and digesta samples by the coupling of Elemental Analysis with stable Isotope Ratio Mass Spectrometry (EA-IRMS) and the amino acid concentration in meal, digesta and plasma samples will be measured by High Performance Liquid Chromatography (HPLC) in order to determine the ileal bioavailability of amino acid of zein and whey protein. Plasma hormonal profile will also be determined to evaluate the effect of each protein sources on metabolic hormones such as insulin, glucagon, leptin, etc.
- Conditions
- Amino Acid
- Being tested
- Whey Protein Isolate 894 Fonterra, Zein Sigma-Aldrich W555025, Protein-free test-meal
- Keywords
- digestibility, whey protein, zein, bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein Isolate 894 FonterraOther
30 g of protein powder diluted in water
Zein Sigma-Aldrich W555025Other
30 g of protein powder diluted in water
Protein-free test-mealOther
No protein included in the drink made of water and flavour/sugar
| Study group | Role | What they receive |
|---|---|---|
| Zein protein | Experimental | Zein protein included in the test-meal, 30 g of zein in 500 ml (water + flavour/sugar) Receives: Other: Zein Sigma-Aldrich W555025 |
| Whey protein isolate | Experimental | Whey protein isolate included in the test-meal, 30 g of zein in 500 ml (water + flavour/sugar) Receives: Other: Whey Protein Isolate 894 Fonterra |
| Protein-free | Other | No protein added in the test-meal, only 500 ml of water + flavour/sugar In order to determine the endogenous loss of amino acid in the digesta samples. Receives: Other: Protein-free test-meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the concentration of amino acids from dietary sources (whey or zein) in the ileal digesta collected during 9 hours after meal intake to calculate the digestibility of amino acids from whey or zein protein sources.
The quantity of amino acids will be determined by HPLC in the ileal digesta collected thanks to the naso-ileal tube during 9 hours after the meal intake. The obligatory endogenous amino acid losses will be estimated by determination of the amino acid content of ileal digesta after intake of the protein-free meal and this value will be subtracted to the values obtained after intake of protein meal to evaluate the quantity of amino acid which comes from dietary sources. Recovery of the indigestible markers (13C-inulin and celite) will allow correction for incomplete collection of digesta.
Measured: Hour 0 to 9 after intake
Secondary outcomes (3)
Determination of the metabolic hormones plasma profile after zein or whey protein intake
Blood will be collected hourly during the 9 hours following the intake of the meal containing zein or whey protein. The profile of concentration of metabolic hormones (amylin, C-peptide, ghrelin, gastric inhibitory polypeptide, glucagon-like peptide 1, glucagon, interleukin -6, insulin, leptin, pancreatic polypeptide, polypeptide tyrosine tyrosine , tumor necrosis factor -α) in plasma will be determined by multiplex hormones assays kit.
Measured: Hour 0 to 9 after intake
Determination of the effect of zein and whey protein on glucose homeostasis
Subjects are administered oral deuterated water the day before the investigation. Gluconeogenesis is assessed by measuring deuterium enrichment in body water and on C5 glucose position.
Measured: From the evening before the administration to 9 h after the meal.
Determination of the effect of zein and whey protein on amino acid plasma concentration
Blood will be collected hourly during the 9 hours following the intake of the meal containing zein or whey protein. The profile of concentration of amino acids in plasma will be determined by ultra high performance liquid chromatography.
Measured: From the evening before the administration to 9 h after the meal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Oct 2017
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
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 Amino AcidStudies 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
- Model description
- 3 groups, one for each protein sources (zein and whey) and one for determination of endogenous amino acid losses (protein-free meal)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- 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
- NCT03279211
- Sponsor's protocol ID
- PROTEOS
- Status last verified
- May 2022
- First submitted
- 18 Jul 2017
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Calvez J, Benoit S, Piedcoq J, Khodorova N, Azzout-Marniche D, Tome D, Benamouzig R, Airinei G, Gaudichon C. Very low ileal nitrogen and amino acid digestibility of zein compared to whey protein isolate in healthy volunteers. Am J Clin Nutr. 2021 Jan 4;113(1):70-82. doi: 10.1093/ajcn/nqaa274.
PubMed 33021640
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- True Ileal Amino Acid Digestibility of Whey and Zein Proteins in Healthy Volunteers With Naso-ileal Tubes
- ClinicalTrials.gov ID
- NCT03279211
- Acronym / sponsor ID
- PROTEOS
- Conditions
- Amino Acid
- Keywords
- digestibility, whey protein, zein, bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 12 Sep 2017 (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 main goal of the study is to determine true ileal amino acid digestibility of whey protein isolate (WPI) and zein proteins in healthy subjects equipped with naso-ileal tube. The endogenous losses of proteins and amino acids will be determined by collecting digesta samples after a protein-free diet in a third group of subjects.
Detailed description
True ileal amino acid digestibility of whey protein isolate (WPI) and zein proteins will be determined in healthy subjects. The endogenous losses of proteins and amino acids will be determined by collecting digesta samples after a protein-free test-meal in a different group of subjects.
24 volunteers will be included in the study (men and women; aged 18-65 y; BMI 18-30 kg/m2) and tested at AgroParisTech (Human Nutrition Research Centre of Avicenne Hospital). Due to the invasive procedure of intubation, each volunteer will test only one test-meal (n=8 / test-meal).
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 hospital the morning before the day of the experiment and will be equipped with a double lumen intestinal tube that will be allowed to progress through the intestinal tract for 24h. 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. A perfusion of the non-absorbable marker polyethylene glycol -4000 will start to estimate the intestinal flow and the basal ileal sample will be collected during 30 min. Basal plasma sample will be collected. Then, at t=0, the volunteer will drink the test-meal. Until t=9h, intestinal content will be continuously collected by aspiration and pooled every 30 minutes. Blood will be sampled every 30 minutes during 4h and hourly thereafter.
The test meal will consist of a protein-free biscuit (160 g) and a drink (500 ml) with the test protein as the sole source of protein or no protein for the protein-free group. Celite will be added to the protein-free biscuit and inulin labelled with carbon 13 will be added to the drink as indigestible markers of the meal to allow correction for incomplete collection of digesta. The test proteins will be WPI or zein.
The total nitrogen will be measured in meal and digesta samples by the coupling of Elemental Analysis with stable Isotope Ratio Mass Spectrometry (EA-IRMS) and the amino acid concentration in meal, digesta and plasma samples will be measured by High Performance Liquid Chromatography (HPLC) in order to determine the ileal bioavailability of amino acid of zein and whey protein. Plasma hormonal profile will also be determined to evaluate the effect of each protein sources on metabolic hormones such as insulin, glucagon, leptin, etc.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3 groups, one for each protein sources (zein and whey) and one for determination of endogenous amino acid losses (protein-free meal)
| Arm | Type | Receives |
|---|---|---|
| Zein protein | Experimental | Other: Zein Sigma-Aldrich W555025Zein protein included in the test-meal, 30 g of zein in 500 ml (water + flavour/sugar) |
| Whey protein isolate | Experimental | Other: Whey Protein Isolate 894 FonterraWhey protein isolate included in the test-meal, 30 g of zein in 500 ml (water + flavour/sugar) |
| Protein-free | Other | Other: Protein-free test-mealNo protein added in the test-meal, only 500 ml of water + flavour/sugar In order to determine the endogenous loss of amino acid in the digesta samples. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Normal body weight (18 < BMI < 30 kg.m-2)
- Women or men
- 18 - 65 y
- Healthy
- Insured under the French social security system
Key exclusion criteria (10 listed)
- People under trusteeship
- Latex, cow milk or corn allergy A
- HIV, hepatite C virus antibodies, hepatite B virus surface antigen and core antibodies positive
- Pregnant women
- Excessive alcohol drinking or drugs intake
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 |
|---|---|---|
| Whey Protein Isolate 894 Fonterra30 g of protein powder diluted in water | Other | Whey protein isolate |
| Zein Sigma-Aldrich W55502530 g of protein powder diluted in water | Other | Zein protein |
| Protein-free test-mealNo protein included in the drink made of water and flavour/sugar | Other | Protein-free |
Primary outcome
Determination of the concentration of amino acids from dietary sources (whey or zein) in the ileal digesta collected during 9 hours after meal intake to calculate the digestibility of amino acids from whey or zein protein sources.
Time frame: Hour 0 to 9 after intake
The quantity of amino acids will be determined by HPLC in the ileal digesta collected thanks to the naso-ileal tube during 9 hours after the meal intake. The obligatory endogenous amino acid losses will be estimated by determination of the amino acid content of ileal digesta after intake of the protein-free meal and this value will be subtracted to the values obtained after intake of protein meal to evaluate the quantity of amino acid which comes from dietary sources. Recovery of the indigestible markers (13C-inulin and celite) will allow correction for incomplete collection of digesta.
3 secondary outcomes
Determination of the metabolic hormones plasma profile after zein or whey protein intake
Time frame: Hour 0 to 9 after intake
Determination of the effect of zein and whey protein on glucose homeostasis
Time frame: From the evening before the administration to 9 h after the meal.
Determination of the effect of zein and whey protein on amino acid plasma concentration
Time frame: From the evening before the administration to 9 h after the meal.
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 3 Jun 2022.
- Derived from this study: PubMed 33021640Calvez J, Benoit S, Piedcoq J, Khodorova N, Azzout-Marniche D, Tome D, Benamouzig R, Airinei G, Gaudichon C. Very low ileal nitrogen and amino acid digestibility of zein compared to whey protein isolate in healthy volunteers. Am J Clin Nutr. 2021 Jan 4;113(1):70-82. doi: 10.1093/ajcn/nqaa274.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein Isolate 894 Fonterra, Zein Sigma-Aldrich W555025 and Protein-free test-meal in people with Amino Acid, 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 7 inclusion and 10 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 3 Jun 2022. 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?
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?
Determination of the concentration of amino acids from dietary sources (whey or zein) in the ileal digesta collected during 9 hours after meal intake to calculate the digestibility of amino acids from whey or zein protein sources. (time frame: Hour 0 to 9 after intake). 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 NCT03279211, 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 3 Jun 2022.