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Protein Nutrition During Weight Loss (SURPROL-CF-H)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00690781
Recruitment Status : Completed
First Posted : June 5, 2008
Last Update Posted : January 27, 2011
Sponsor:
Collaborators:
Centre de Recherche en Nutrition Humaine d'Auvergne
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Université d'Auvergne
Information provided by:
Institut National de la Recherche Agronomique

Tracking Information
First Submitted Date  ICMJE May 30, 2008
First Posted Date  ICMJE June 5, 2008
Last Update Posted Date January 27, 2011
Study Start Date  ICMJE May 2008
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2008)
Lean body mass [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2008)
  • Nitrogen balance [ Time Frame: 6 weeks ]
  • whole body leucine turnover [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protein Nutrition During Weight Loss
Official Title  ICMJE Effect of Milk Proteins and Protein Feeding Pattern on Body Composition and Protein Metabolism in Energy Restricted Obese Subjects
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
Detailed Description

In most physiological situations, the adequate amount of protein necessary to promote health is more and more well known. However, for an adequate protein intake, it was shown that the kinetic of amino acid delivery to the organism has an influence on the efficiency of protein utilization. In particular, caseins, slowly digested milk proteins, promote a better protein balance than rapidly digested milk soluble proteins in young subjects (Boirie et al., 1997). In addition, changing protein feeding pattern (80% of daily protein consumed at noon vs 25%) significantly affect protein balance (Arnal et al., 2000). In young healthy individuals, the best protein efficiency is obtained by spreading protein absorption over time (casein, and/or 4 isoproteic meal per day). On the contrary, in older individuals, due to alteration in the sensitivity of protein metabolism to feeding, it is better to use rapidly digested proteins (Dangin et al., 2003), and / or to have a protein-rich meal once a day (Arnal et al., 1999).

Another physiological situation that was not studied in this regard is obesity. Obesity incidence is rapidly increasing around the world. When body mass index (weight / height2) becomes too high (>30), it is often suggested to restrict energy intake. However, severe energy restriction leads to fat mass loss, but also to lean body mass loss, which should be prevented. Our aim is to test whether for an adequate amount of total protein, it is possible to preserve lean body mass by using either casein, or milk soluble proteins, or by changing protein feeding pattern.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Obesity
Intervention  ICMJE
  • Dietary Supplement: Pulse casein feeding during energy restriction
    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).
  • Dietary Supplement: Spread casein feeding during energy restriction
    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).
  • Dietary Supplement: Pulse milk soluble protein feeding during energy restriction
    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).
  • Dietary Supplement: Spread milk soluble protein feeding during energy restriction
    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).
Study Arms  ICMJE
  • Experimental: Casein Pulse
    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.
    Intervention: Dietary Supplement: Pulse casein feeding during energy restriction
  • Experimental: Casein Spread
    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.
    Intervention: Dietary Supplement: Spread casein feeding during energy restriction
  • Experimental: MSP Pulse
    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.
    Intervention: Dietary Supplement: Pulse milk soluble protein feeding during energy restriction
  • Experimental: MSP Spread
    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.
    Intervention: Dietary Supplement: Spread milk soluble protein feeding during energy restriction
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 4, 2008)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI>30
  • sedentary
  • normal TSH

Exclusion Criteria:

  • any serious health problem
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00690781
Other Study ID Numbers  ICMJE AU 724
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michel Beckert, Institut National de la Recherche Agronomique
Study Sponsor  ICMJE Institut National de la Recherche Agronomique
Collaborators  ICMJE
  • Centre de Recherche en Nutrition Humaine d'Auvergne
  • French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
  • Université d'Auvergne
Investigators  ICMJE
Principal Investigator: Yves Boirie, MD, Ph D, Professor Université d'Auvergne, CHU de Clermont-Ferrand, Institut National de la Recherche Agronomique
PRS Account Institut National de la Recherche Agronomique
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP