Protein DigestionNCT04282096
Nutritional Caracterisation of Micellar Casein
A study testing native and non native casein in people with Protein Digestion, run by Ingredia S.A. at 1 site in France.
Trial summary
There are different types of casein on the market, which differ according to their chemical or physical process of obtaining. The processes will impact structural differences in the macromolecular assembly. The majority of caseins marketed in nutrition are casein in the form of Na caseinate or Ca caseinate. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Protein Digestion
- What is being tested?
- native and non native casein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 23 Aug 2018to 5 Nov 2018
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Aged 20 to 40 years
- BMI : 18.5-30 Kg/m2
- Healthy (apparently free of diseases)
- Without dietary supplement the last month
- Without allergy, lactose intolerance or aversion for milk protein
- Moderately physically active
- Affiliated to National Health Insurance
- Having provided her written informed consent
Who cannot join
- Following any kind of treatment
- Smokers (>5 cigarets/d)
- Vegetarian, vegan
- Individual unable to give informed consent or refusing to sign informed consent
- Being in exclusion on the National Volunteers Data file or refusing to be registered on the National Volunteers Data file
- Currently participating or who having got 4500€ in this year before to have participating in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
There are different types of casein on the market, which differ according to their chemical or physical process of obtaining. The processes will impact structural differences in the macromolecular assembly.
The majority of caseins marketed in nutrition are casein in the form of Na caseinate or Ca caseinate.
Read more
The micellar caseins obtained by membrane filtration (physical process) are more and more used in the nutrition market.
The development of casein extraction with different structures on an industrial scale opens up other perspectives for these proteins, particularly in terms of health.
The main objective of this project is to study the postprandial kinetics of the plasma concentrations of the essential amino acids of three structurally different types of caseins.
The secondary objective is to study the speed of gastric emptying and the nutritional properties of different proteins.
Read the detailed description
All the participants will give freely their written informed consent before their selection in the study.
Each subject will participate in 3 kinetics of 5 hours with a different product test each time, in a randomized order. A wash-out period of at least 7 days will be respected between each kinetics. The products to be tested will be in the form of a powder (25g individual sachet, including 20.1g of protein) which will be reconstituted in 250ml of water and to which 100mg of 13C sodium acetate will be added.
For each of the kinetics, blood samples, expires gasses, will be collected at different time during the kinetics. A urinary collection throughout the day of kinetics will also be performed to allow the determination of urinary nitrogen Indirect calorimetry measurements will be performed 45 minutes every hour in the postprandial period and a measurement of 45 minutes will be made when the subject is fasting. Six measurements of indirect calorimetry will be performed for each kinetic.
Finally subjects will be asked to evaluate their satiety on a visual analog scale, 15' before taking the product, then every 15' the first hour in the postprandial period and every 30 'from the 2nd hour.
The subjects will also have a tolerance questionnaire to complete with each kinetic.
At the end of the kinetics, a standardized meal, single menu, consumption ad libitum measured in double weighing will be proposed to the volunteers to evaluate their satiety
During the 3 days preceding each kinetics, the protein intake of the subjects will be controlled. The meal of each night in the evening of kinetics will be standardized and identical for each kinetics. The volunteers will complete a food survey on the 3 days of control of their diet that precede each kinetics.
- Conditions
- Protein Digestion
- Being tested
- native and non native casein
- Keywords
- Micellar casein, Bioavailibility, Gastric emptying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
native and non native caseinOther
selected participant will test the 3 treatments in a random order
| Study group | Role | What they receive |
|---|---|---|
| Caseine micellar | Experimental | Not described Receives: Other: native and non native casein |
| Sodium Casein | Other | Not described Receives: Other: native and non native casein |
| Calcium casein | Other | Not described Receives: Other: native and non native casein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the plasma concentrations of the essential amino acids of 3 structurally different types of caseins during postprandial kinetics
Maximum total plasma concentration of the essential amino acids measured during different points of the 5 hours of the kinetics (one kinetic / type of casein). One point before (basal) and several points (15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes) after the consumption of one of the 3 types of caseins
Measured: before and during 300 minutes after product consumption
Secondary outcomes (8)
Maximum plasma concentration for non essential amino acids
Maximum total plasma concentration of the non essential amino acids measured during different points of the 5 hours of the kinetics (one kinetic / type of casein). One point before (basal) and several points (15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes) after the consumption of one of the 3 types of caseins
Measured: before and during 300 minutes after product consumption
Tmax
Time in minutes to obtain the maximal total plasma concentration of essential amino acides
Measured: before and during 300 minutes after product consumption
Measurement of gastric emptying by the 13C sodium acetate method
Time to obtain the maximum expired 13CO2 concentration (Tmax)
Measured: before and during 300 minutes after product consumption
gastric emptying at 50% (T 1/2)
Obtaining time for gastric emptying at 50% (T 1/2)
Measured: before and during 300 minutes after product consumption
Thermogenic effect of proteins at different times of kinetics
Oxidation of substrates (lipids, proteins, carbohydrates) (g/min) by indirect respiratory calorimetry corrected for nitrogen excretion.
Measured: before and during 300 minutes after product consumption
Satietogenic effect of proteins evaluated using a visual analogue scale at different times of kinetics
Measured by a visual analogue scale 100mm in length with words anchored at each end, expressing the most positive and the most negative rating, were used to assess hunger, satiety, fullness, prospective food consumption.
Measured: from product consumption until 300 minutes after
Tolerance of products assessed by a questionnaire
Measured: at 300 minutes after product consumption
Changes in the plasma concentrations of insulin at different times of kinetics
Measured: before and during 300 minutes after product consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start23 Aug 2018
- Primary completion30 Oct 2018
- Study completion5 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein DigestionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ingredia S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Pr Ruddy Richard, Centre de Recherche en Nutrition Humaine d'Auvergne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282096
- Sponsor's protocol ID
- ID RCB 2017-A03192-51
- Other IDs
- CRNH 2017-4
- Status last verified
- Feb 2020
- First submitted
- 6 Nov 2018
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Caracterisation of Micellar Casein
- ClinicalTrials.gov ID
- NCT04282096
- Acronym / sponsor ID
- ID RCB 2017-A03192-51
- Conditions
- Protein Digestion
- Keywords
- Micellar casein, Bioavailibility, Gastric emptying
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ingredia S.A.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 5 Nov 2018 (actual)
- First posted
- 24 Feb 2020 (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.
There are different types of casein on the market, which differ according to their chemical or physical process of obtaining. The processes will impact structural differences in the macromolecular assembly.
The majority of caseins marketed in nutrition are casein in the form of Na caseinate or Ca caseinate.
The micellar caseins obtained by membrane filtration (physical process) are more and more used in the nutrition market.
The development of casein extraction with different structures on an industrial scale opens up other perspectives for these proteins, particularly in terms of health.
The main objective of this project is to study the postprandial kinetics of the plasma concentrations of the essential amino acids of three structurally different types of caseins.
The secondary objective is to study the speed of gastric emptying and the nutritional properties of different proteins.
Detailed description
All the participants will give freely their written informed consent before their selection in the study.
Each subject will participate in 3 kinetics of 5 hours with a different product test each time, in a randomized order. A wash-out period of at least 7 days will be respected between each kinetics. The products to be tested will be in the form of a powder (25g individual sachet, including 20.1g of protein) which will be reconstituted in 250ml of water and to which 100mg of 13C sodium acetate will be added.
For each of the kinetics, blood samples, expires gasses, will be collected at different time during the kinetics. A urinary collection throughout the day of kinetics will also be performed to allow the determination of urinary nitrogen Indirect calorimetry measurements will be performed 45 minutes every hour in the postprandial period and a measurement of 45 minutes will be made when the subject is fasting. Six measurements of indirect calorimetry will be performed for each kinetic.
Finally subjects will be asked to evaluate their satiety on a visual analog scale, 15' before taking the product, then every 15' the first hour in the postprandial period and every 30 'from the 2nd hour.
The subjects will also have a tolerance questionnaire to complete with each kinetic.
At the end of the kinetics, a standardized meal, single menu, consumption ad libitum measured in double weighing will be proposed to the volunteers to evaluate their satiety
During the 3 days preceding each kinetics, the protein intake of the subjects will be controlled. The meal of each night in the evening of kinetics will be standardized and identical for each kinetics. The volunteers will complete a food survey on the 3 days of control of their diet that precede each kinetics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caseine micellar | Experimental | Other: native and non native casein |
| Sodium Casein | Other | Other: native and non native casein |
| Calcium casein | Other | Other: native and non native casein |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- - Aged 20 to 40 years
- BMI : 18.5-30 Kg/m2
- Healthy (apparently free of diseases)
- Without dietary supplement the last month
- Without allergy, lactose intolerance or aversion for milk protein
Key exclusion criteria (6 listed)
- Following any kind of treatment
- Smokers (>5 cigarets/d)
- Vegetarian, vegan
- Individual unable to give informed consent or refusing to sign informed consent
- Being in exclusion on the National Volunteers Data file or refusing to be registered on the National Volunteers Data file
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 |
|---|---|---|
| native and non native caseinselected participant will test the 3 treatments in a random order | Other | Calcium casein, Caseine micellar, Sodium Casein |
Primary outcome
Changes in the plasma concentrations of the essential amino acids of 3 structurally different types of caseins during postprandial kinetics
Time frame: before and during 300 minutes after product consumption
Maximum total plasma concentration of the essential amino acids measured during different points of the 5 hours of the kinetics (one kinetic / type of casein). One point before (basal) and several points (15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes) after the consumption of one of the 3 types of caseins
8 secondary outcomes
Maximum plasma concentration for non essential amino acids
Time frame: before and during 300 minutes after product consumption
Tmax
Time frame: before and during 300 minutes after product consumption
Measurement of gastric emptying by the 13C sodium acetate method
Time frame: before and during 300 minutes after product consumption
gastric emptying at 50% (T 1/2)
Time frame: before and during 300 minutes after product consumption
Thermogenic effect of proteins at different times of kinetics
Time frame: before and during 300 minutes after product consumption
Satietogenic effect of proteins evaluated using a visual analogue scale at different times of kinetics
Time frame: from product consumption until 300 minutes after
Tolerance of products assessed by a questionnaire
Time frame: at 300 minutes after product consumption
Changes in the plasma concentrations of insulin at different times of kinetics
Time frame: before and during 300 minutes after product consumption
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 24 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Protein Digestion
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
Active, not recruiting
Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring
Breast Cancer, Lung Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
RecruitingObservational study
Cancer Experience Registry (CER) for Cancer Patients and Caregivers
Neoplasms, Cancer
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 native and non native casein in people with Protein Digestion, run by Ingredia S.A. 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 8 inclusion and 6 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 24 Feb 2020. 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?
Changes in the plasma concentrations of the essential amino acids of 3 structurally different types of caseins during postprandial kinetics (time frame: before and during 300 minutes after product consumption). 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 24 Feb 2020.