NCT04282096

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 6, 2018

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

February 24, 2020

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

November 6, 2018

Last Update Submit

February 20, 2020

Conditions

Protein Digestion

Keywords

Micellar caseinBioavailibilityGastric emptying

Outcome Measures

Primary Outcomes (1)

  • 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

    before and during 300 minutes after product consumption

Secondary Outcomes (8)

  • Maximum plasma concentration for non essential amino acids

    before and during 300 minutes after product consumption

  • Tmax

    before and during 300 minutes after product consumption

  • Measurement of gastric emptying by the 13C sodium acetate method

    before and during 300 minutes after product consumption

  • gastric emptying at 50% (T 1/2)

    before and during 300 minutes after product consumption

  • Thermogenic effect of proteins at different times of kinetics

    before and during 300 minutes after product consumption

  • +3 more secondary outcomes

Study Arms (3)

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

Interventions

native and non native caseinOTHER

selected participant will test the 3 treatments in a random order

Calcium caseinCaseine micellarSodium Casein

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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

You may not qualify if:

  • Following any kind of treatment
  • Smokers (\>5 cigarets/d)
  • Vegetarian, vegan
  • Individual unable to give informed consent or refusing to sign informed consent
  • Currently participating or who having got 4500€ in this year before to have participating in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche en Nutrition Humaine

Clermont-Ferrand, 63009, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
double blind
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

November 6, 2018

First Posted

February 24, 2020

Study Start

August 23, 2018

Primary Completion

October 30, 2018

Study Completion

November 5, 2018

Last Updated

February 24, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)