NCT00862329

Brief Summary

Dietary protein is the more satiating nutrient, however it is not clear whether satiety may be influenced by the nature of the protein. This study was designed to assess potential differences between protein sources on satiety and their relationship with digestive and metabolic kinetics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

March 22, 2012

Status Verified

March 1, 2012

Enrollment Period

1.3 years

First QC Date

March 13, 2009

Last Update Submit

March 21, 2012

Conditions

Keywords

Healthy subjects

Outcome Measures

Primary Outcomes (1)

  • satiety

    7 days

Secondary Outcomes (1)

  • hormonal profiles, digestive fluxes of nutrients, postprandial dietary N metabolism

    9 days

Study Arms (4)

Casein

EXPERIMENTAL
Dietary Supplement: Casein-enriched diet

MSP

EXPERIMENTAL
Dietary Supplement: Milk soluble protein-enriched diet

Casein/MSP

EXPERIMENTAL
Dietary Supplement: Casein and milk soluble proteins-enriched diet

Soy protein

EXPERIMENTAL
Dietary Supplement: Soy proteins-enriched diet

Interventions

Casein-enriched dietDIETARY_SUPPLEMENT

Subjects consume for 9 days a supplement of 30g/d of casein

Casein

Subjects consume for 9 days a supplement of 30g/d of milk soluble protein

MSP

Subjects consume for 9 days a supplement of 30g/d of a mix of casein and milk soluble protein

Casein/MSP
Soy proteins-enriched dietDIETARY_SUPPLEMENT

Subjects consume for 9 days a supplement of 30g/d of soy protein

Soy protein

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 25 and 30

You may not qualify if:

  • allergy to milk proteins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche sur volontaires

Bobigny, 93, France

Location

Related Publications (2)

  • Marsset-Baglieri A, Fromentin G, Airinei G, Pedersen C, Leonil J, Piedcoq J, Remond D, Benamouzig R, Tome D, Gaudichon C. Milk protein fractions moderately extend the duration of satiety compared with carbohydrates independently of their digestive kinetics in overweight subjects. Br J Nutr. 2014 Aug 28;112(4):557-64. doi: 10.1017/S0007114514001470. Epub 2014 Jun 26.

  • Boutrou R, Gaudichon C, Dupont D, Jardin J, Airinei G, Marsset-Baglieri A, Benamouzig R, Tome D, Leonil J. Sequential release of milk protein-derived bioactive peptides in the jejunum in healthy humans. Am J Clin Nutr. 2013 Jun;97(6):1314-23. doi: 10.3945/ajcn.112.055202. Epub 2013 Apr 10.

MeSH Terms

Interventions

Caseins

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsPhosphoproteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Manager of the HNRC

Study Record Dates

First Submitted

March 13, 2009

First Posted

March 16, 2009

Study Start

March 1, 2008

Primary Completion

June 1, 2009

Study Completion

November 1, 2010

Last Updated

March 22, 2012

Record last verified: 2012-03

Locations