Protein Nutrition During Weight Loss

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Milk Proteins and Protein Feeding Pattern on Body Composition and Protein Metabolism in Energy Restricted Obese Subjects

Conditions
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Obesity

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI>30 sedentary normal TSH Exclusion Criteria: any serious health problem

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Casein Pulse<br>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<br>* 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).<br>|
| Experimental: Casein Spread<br>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<br>* 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).<br>|
| Experimental: MSP Pulse<br>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<br>* 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).<br>|
| Experimental: MSP Spread<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean body mass |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nitrogen balance |  | 6 weeks | 
| whole body leucine turnover |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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milk soluble proteins, casein, protein feeding pattern, overweight, obesity, energy restriction, protein metabolism, lean body mass, body composition, nitrogen balance, protein synthesis, proteolysis, spread, pulse