NCT00690781

Brief Summary

The purpose of this study is to minimize the loss of lean body mass that occurs during a weight-loss program in obese people by changing the nature of ingested protein and the pattern of protein feeding

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2008

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

May 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

January 27, 2011

Status Verified

January 1, 2011

Enrollment Period

2.2 years

First QC Date

May 30, 2008

Last Update Submit

January 26, 2011

Conditions

Obesity

Keywords

caseinmilk soluble proteinsprotein feeding patternoverweightobesityenergy restrictionprotein metabolismlean body massbody compositionnitrogen balanceprotein synthesisproteolysisspreadpulse

Outcome Measures

Primary Outcomes (1)

  • Lean body mass

    6 weeks

Secondary Outcomes (2)

  • Nitrogen balance

    6 weeks

  • whole body leucine turnover

    6 weeks

Study Arms (4)

Casein Pulse

EXPERIMENTAL

casein is the main protein consumed, it is given during 6 weeks with a "pulse" protein feeding pattern : 8% for breakfast, 80% for lunch, 4% around 1600h, and 8% for dinner.

Dietary Supplement: Pulse casein feeding during energy restriction

Casein Spread

EXPERIMENTAL

casein is the main protein consumed, it is given during 6 weeks with a "spread" protein feeding pattern : 25% for breakfast, 25% for lunch, 25% around 1600h, and 25% for dinner.

Dietary Supplement: Spread casein feeding during energy restriction

MSP Pulse

EXPERIMENTAL

Milk soluble proteins (MSP) are the main protein consumed, it is given during 6 weeks with a "pulse" protein feeding pattern : 8% for breakfast, 80% for lunch, 4% around 1600h, and 8% for dinner.

Dietary Supplement: Pulse milk soluble protein feeding during energy restriction

MSP Spread

EXPERIMENTAL

Milk soluble proteins (MSP) are the main protein consumed, it is given during 6 weeks with a "spread" protein feeding pattern : 25% for breakfast, 25% for lunch, 25% around 1600h, and 25% for dinner.

Dietary Supplement: Spread milk soluble protein feeding during energy restriction

Interventions

Pulse casein feeding during energy restrictionDIETARY_SUPPLEMENT

Obese subjects are subjected to a 35% energy restriction during 6 weeks and during this period, 25% of energy is given as protein, these proteins being casein. In addition, a pulse protein feeding pattern is used (8% protein in the morning, 80% for lunch, 4% at 1600 h and 8% in the evening).

Casein Pulse
Spread casein feeding during energy restrictionDIETARY_SUPPLEMENT

Obese subjects are subjected to a 35% energy restriction during 6 weeks and during this period, 25% of energy is given as protein, these proteins being casein. In addition, a spread protein feeding pattern is used (25% of protein at each of the four meals of the day).

Casein Spread
Pulse milk soluble protein feeding during energy restrictionDIETARY_SUPPLEMENT

Obese subjects are subjected to a 35% energy restriction during 6 weeks and during this period, 25% of energy is given as protein, these proteins being milk soluble proteins. In addition, a pulse protein feeding pattern is used (8% protein in the morning, 80% for lunch, 4% at 1600 h and 8% in the evening).

MSP Pulse
Spread milk soluble protein feeding during energy restrictionDIETARY_SUPPLEMENT

Obese subjects are subjected to a 35% energy restriction during 6 weeks and during this period, 25% of energy is given as protein, these proteins being milk soluble proteins. In addition, a spread protein feeding pattern is used (25% of protein at each of the four meals of the day).

MSP Spread

Eligibility Criteria

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

You may qualify if:

  • BMI\>30
  • sedentary
  • normal TSH

You may not qualify if:

  • any serious health problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité d'Exploration Nutritionnelle (Nutritional Exploration Unit)

Clermont-Ferrand, France, 63009, France

Location

Related Publications (6)

  • Arnal MA, Mosoni L, Boirie Y, Houlier ML, Morin L, Verdier E, Ritz P, Antoine JM, Prugnaud J, Beaufrere B, Mirand PP. Protein pulse feeding improves protein retention in elderly women. Am J Clin Nutr. 1999 Jun;69(6):1202-8. doi: 10.1093/ajcn/69.6.1202.

    PMID: 10357740BACKGROUND

  • Arnal MA, Mosoni L, Boirie Y, Houlier ML, Morin L, Verdier E, Ritz P, Antoine JM, Prugnaud J, Beaufrere B, Mirand PP. Protein feeding pattern does not affect protein retention in young women. J Nutr. 2000 Jul;130(7):1700-4. doi: 10.1093/jn/130.7.1700.

    PMID: 10867039BACKGROUND

  • Boirie Y, Dangin M, Gachon P, Vasson MP, Maubois JL, Beaufrere B. Slow and fast dietary proteins differently modulate postprandial protein accretion. Proc Natl Acad Sci U S A. 1997 Dec 23;94(26):14930-5. doi: 10.1073/pnas.94.26.14930.

    PMID: 9405716BACKGROUND

  • Dangin M, Guillet C, Garcia-Rodenas C, Gachon P, Bouteloup-Demange C, Reiffers-Magnani K, Fauquant J, Ballevre O, Beaufrere B. The rate of protein digestion affects protein gain differently during aging in humans. J Physiol. 2003 Jun 1;549(Pt 2):635-44. doi: 10.1113/jphysiol.2002.036897. Epub 2003 Mar 28.

    PMID: 12665610BACKGROUND

  • Dardevet D, Sornet C, Bayle G, Prugnaud J, Pouyet C, Grizard J. Postprandial stimulation of muscle protein synthesis in old rats can be restored by a leucine-supplemented meal. J Nutr. 2002 Jan;132(1):95-100. doi: 10.1093/jn/132.1.95.

    PMID: 11773514BACKGROUND

  • Lacroix M, Bos C, Leonil J, Airinei G, Luengo C, Dare S, Benamouzig R, Fouillet H, Fauquant J, Tome D, Gaudichon C. Compared with casein or total milk protein, digestion of milk soluble proteins is too rapid to sustain the anabolic postprandial amino acid requirement. Am J Clin Nutr. 2006 Nov;84(5):1070-9. doi: 10.1093/ajcn/84.5.1070.

    PMID: 17093159BACKGROUND

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yves Boirie, MD, Ph D, Professor

    Université d'Auvergne, CHU de Clermont-Ferrand, Institut National de la Recherche Agronomique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 5, 2008

Study Start

May 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

January 27, 2011

Record last verified: 2011-01

Locations

FR(1)