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

This study has been completed.
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)
PRES Clermont University of Auvergne, Occupational Medicine, Faculty of Medicine, 63000 Clermont-Ferrand, France
Information provided by:
Institut National de la Recherche Agronomique
ClinicalTrials.gov Identifier:
NCT00690781
First received: May 30, 2008
Last updated: January 26, 2011
Last verified: January 2011
  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

Resource links provided by NLM:


Further study details as provided by Institut National de la Recherche Agronomique:

Primary Outcome Measures:
  • Lean body mass [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • BMI>30
  • sedentary
  • normal TSH

Exclusion Criteria:

  • any serious health problem
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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)
PRES Clermont University of Auvergne, Occupational Medicine, Faculty of Medicine, 63000 Clermont-Ferrand, France
Investigators
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
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014