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

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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

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

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Pulse casein feeding during energy restriction Dietary Supplement: Spread casein feeding during energy restriction Dietary Supplement: Pulse milk soluble protein feeding during energy restriction Dietary Supplement: Spread milk soluble protein feeding during energy restriction Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Milk Proteins and Protein Feeding Pattern on Body Composition and Protein Metabolism in Energy Restricted Obese Subjects
Study Start Date : May 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control
Drug Information available for: Casein
U.S. FDA Resources

Arm Intervention/treatment
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.
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).
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.
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).
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.
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).
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.
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).



Primary Outcome Measures :
  1. Lean body mass [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Nitrogen balance [ Time Frame: 6 weeks ]
  2. whole body leucine turnover [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI>30
  • sedentary
  • normal TSH

Exclusion Criteria:

  • any serious health problem

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690781


Locations
France
Unité d'Exploration Nutritionnelle (Nutritional Exploration Unit)
Clermont-Ferrand, France, 63009
Sponsors and Collaborators
Institut National de la Recherche Agronomique
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
Principal Investigator: Yves Boirie, MD, Ph D, Professor Université d'Auvergne, CHU de Clermont-Ferrand, Institut National de la Recherche Agronomique

Publications:
Responsible Party: Michel Beckert, Institut National de la Recherche Agronomique
ClinicalTrials.gov Identifier: NCT00690781     History of Changes
Other Study ID Numbers: AU 724
First Posted: June 5, 2008    Key Record Dates
Last Update Posted: January 27, 2011
Last Verified: January 2011

Keywords provided by Institut National de la Recherche Agronomique:
casein
milk soluble proteins
protein feeding pattern
overweight
obesity
energy restriction
protein metabolism
lean body mass
body composition
nitrogen balance
protein synthesis
proteolysis
spread
pulse

Additional relevant MeSH terms:
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action