Protein Nutrition During Weight Loss (SURPROL-CF-H)
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- Lean body mass [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Nitrogen balance [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- whole body leucine turnover [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | May 2008 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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).
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- BMI>30
- sedentary
- normal TSH
Exclusion Criteria:
- any serious health problem
Contacts and Locations| France | |
| Unité d'Exploration Nutritionnelle (Nutritional Exploration Unit) | |
| Clermont-Ferrand, France, 63009 | |
| Principal Investigator: | Yves Boirie, MD, Ph D, Professor | Université d'Auvergne, CHU de Clermont-Ferrand, Institut National de la Recherche Agronomique |
More Information
Publications:
| Responsible Party: | Michel Beckert, Institut National de la Recherche Agronomique |
| ClinicalTrials.gov Identifier: | NCT00690781 History of Changes |
| Other Study ID Numbers: | AU 724 |
| Study First Received: | May 30, 2008 |
| Last Updated: | January 26, 2011 |
| Health Authority: | France: Ministry of Health France: CHU de Clermont-Ferrand |
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:
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight |
Signs and Symptoms Caseins Chelating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013