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

January 26, 2011 updated by: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63009
        • Unité d'Exploration Nutritionnelle (Nutritional Exploration Unit)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI>30
  • sedentary
  • normal TSH

Exclusion Criteria:

  • any serious health problem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lean body mass
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Nitrogen balance
Time Frame: 6 weeks
6 weeks
whole body leucine turnover
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Collaborators

Université d'Auvergne
ANRS, Emerging Infectious Diseases
Centre de Recherche en Nutrition Humaine 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

May 30, 2008

First Submitted That Met QC Criteria

June 4, 2008

First Posted (ESTIMATE)

June 5, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 27, 2011

Last Update Submitted That Met QC Criteria

January 26, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU 724

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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