Nutritional Caracterisation of Micellar Casein

February 20, 2020 updated by: Pr Ruddy Richard, Ingredia S.A.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Clermont Ferrand, France, 63009
        • Centre de Recherche en Nutrition Humaine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • - 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Caseine micellar
selected participant will test the 3 treatments in a random order
Other: Sodium Casein
selected participant will test the 3 treatments in a random order
Other: Calcium casein
selected participant will test the 3 treatments in a random order

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before and during 300 minutes after product consumption

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration for non essential amino acids
Time Frame: before and during 300 minutes after product consumption
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
before and during 300 minutes after product consumption
Tmax
Time Frame: before and during 300 minutes after product consumption
Time in minutes to obtain the maximal total plasma concentration of essential amino acides
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
Time to obtain the maximum expired 13CO2 concentration (Tmax)
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
Obtaining time for gastric emptying at 50% (T 1/2)
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
Oxidation of substrates (lipids, proteins, carbohydrates) (g/min) by indirect respiratory calorimetry corrected for nitrogen excretion.
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
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.
from product consumption until 300 minutes after
Tolerance of products assessed by a questionnaire
Time Frame: at 300 minutes after product consumption
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
before and during 300 minutes after product consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2018

Primary Completion (Actual)

October 30, 2018

Study Completion (Actual)

November 5, 2018

Study Registration Dates

First Submitted

November 6, 2018

First Submitted That Met QC Criteria

February 20, 2020

First Posted (Actual)

February 24, 2020

Study Record Updates

Last Update Posted (Actual)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • ID RCB 2017-A03192-51
  • CRNH 2017-4 (Other Identifier: Centre de Recherche en Nutrition Humaine d'Auvergne)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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