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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pulse casein feeding during energy restriction
Spread casein feeding during energy restriction
Pulse milk soluble protein feeding during energy restriction
Spread milk soluble protein feeding during energy restriction
Sponsored by
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring 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

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI>30
  • sedentary
  • normal TSH

Exclusion Criteria:

  • any serious health problem

Sites / Locations

  • Unité d'Exploration Nutritionnelle (Nutritional Exploration Unit)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Casein Pulse

Casein Spread

MSP Pulse

MSP Spread

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Lean body mass

Secondary Outcome Measures

Nitrogen balance
whole body leucine turnover

Full Information

First Posted
May 30, 2008
Last Updated
January 26, 2011
Sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborators
Centre de Recherche en Nutrition Humaine d'Auvergne, ANRS, Emerging Infectious Diseases, Université d'Auvergne
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1. Study Identification

Unique Protocol Identification Number
NCT00690781
Brief Title
Protein Nutrition During Weight Loss
Acronym
SURPROL-CF-H
Official Title
Effect of Milk Proteins and Protein Feeding Pattern on Body Composition and Protein Metabolism in Energy Restricted Obese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborators
Centre de Recherche en Nutrition Humaine d'Auvergne, ANRS, Emerging Infectious Diseases, Université d'Auvergne

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Casein Pulse
Arm Type
Experimental
Arm Description
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.
Arm Title
Casein Spread
Arm Type
Experimental
Arm Description
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.
Arm Title
MSP Pulse
Arm Type
Experimental
Arm Description
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.
Arm Title
MSP Spread
Arm Type
Experimental
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Pulse casein feeding during energy restriction
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Spread casein feeding during energy restriction
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Pulse milk soluble protein feeding during energy restriction
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Spread milk soluble protein feeding during energy restriction
Intervention Description
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 Measure Information:
Title
Lean body mass
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Nitrogen balance
Time Frame
6 weeks
Title
whole body leucine turnover
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI>30 sedentary normal TSH Exclusion Criteria: any serious health problem
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Boirie, MD, Ph D, Professor
Organizational Affiliation
Université d'Auvergne, CHU de Clermont-Ferrand, Institut National de la Recherche Agronomique
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unité d'Exploration Nutritionnelle (Nutritional Exploration Unit)
City
Clermont-Ferrand
ZIP/Postal Code
63009
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
10357740
Citation
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.
Results Reference
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PubMed Identifier
10867039
Citation
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.
Results Reference
background
PubMed Identifier
9405716
Citation
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.
Results Reference
background
PubMed Identifier
12665610
Citation
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.
Results Reference
background
PubMed Identifier
11773514
Citation
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.
Results Reference
background
PubMed Identifier
17093159
Citation
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.
Results Reference
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Protein Nutrition During Weight Loss

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