Metabolic Effect of High-protein Meals in Men (OPTI-PROT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CDUadmin, Nestlé
ClinicalTrials.gov Identifier:
NCT00712010
First received: July 3, 2008
Last updated: July 12, 2013
Last verified: July 2013
Results First Received: April 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Healthy
Interventions: Other: Whey protein native
Other: Whey protein microgels
Other: Hydrolyzed whey protein
Other: Casein native
Other: Hydrolyzed casein
Other: Total milk protein native
Other: Hydrolyzed milk protein

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited among the Nestlé Research Center staff from June 2008 to May 2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
25 healthy males were recruited; All presented all the inclusion criteria and none of the exclusion criteria listed in the protocol. The day before each test meal, the volunteers were recommended to eat normally as well as to conduct a normal physical activity. A standardized dinner was provided the night before testing.

Reporting Groups
  Description
7 Proteins Were Tested Randomly

Seven high-protein meal replacement (MR) were tested. These high-protein MR contained 29% total energy intake (TEI) of protein, 28% TEI lipids and 43% TEI glucides in 400mL meal, were iso-nitrogenous and differed in their protein quality. The proteins were:

  • intact whey protein
  • whey protein micelles
  • exhaustively hydrolyzed whey protein
  • intact casein protein
  • exhaustively hydrolyzed casein protein
  • total milk protein
  • exhaustively hydrolyzed milk protein The high-protein MR were a 430g liquid meal containing 30g of the tested protein.

Participant Flow for 13 periods

Period 1:   1st Protein Testing (1 Day)
    7 Proteins Were Tested Randomly  
STARTED     24 [1]
COMPLETED     24  
NOT COMPLETED     0  
[1] 1 subject withdrew his consent form before to starting the 1st intervention

Period 2:   Washout (7 Days)
    7 Proteins Were Tested Randomly  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  

Period 3:   2nd Protein Testing (1 Day)
    7 Proteins Were Tested Randomly  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  

Period 4:   Washout (7 Days)
    7 Proteins Were Tested Randomly  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  

Period 5:   3rd Protein Testing (1 Day)
    7 Proteins Were Tested Randomly  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  

Period 6:   Washout (7 Days)
    7 Proteins Were Tested Randomly  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  

Period 7:   4th Protein Testing (1 Day)
    7 Proteins Were Tested Randomly  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  

Period 8:   Washout (7 Days)
    7 Proteins Were Tested Randomly  
STARTED     24  
COMPLETED     23  
NOT COMPLETED     1  
Withdrawal by Subject                 1  

Period 9:   5th Protein Testing (1 Day)
    7 Proteins Were Tested Randomly  
STARTED     23  
COMPLETED     23  
NOT COMPLETED     0  

Period 10:   Washout (7 Days)
    7 Proteins Were Tested Randomly  
STARTED     23  
COMPLETED     23  
NOT COMPLETED     0  

Period 11:   6th Protein Testing (1 Day)
    7 Proteins Were Tested Randomly  
STARTED     23  
COMPLETED     23  
NOT COMPLETED     0  

Period 12:   Washout (7 Days)
    7 Proteins Were Tested Randomly  
STARTED     23  
COMPLETED     23  
NOT COMPLETED     0  

Period 13:   7th and Last Protein Testing (1 Day)
    7 Proteins Were Tested Randomly  
STARTED     23  
COMPLETED     23  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants were recruited amoung the Nestlé Research Center staff.

Reporting Groups
  Description
Entire Study Population Includes groups randomized to receive 7 products in a randomized series

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  25  
Age  
[units: Years]
Mean ± Standard Deviation
  28.3  ± 1.5  
Age, Customized  
[units: participants]
 
<=20 years     0  
Between 20 and 50 years     25  
>=50 years     0  
Gender  
[units: participants]
 
Female     0  
Male     25  
Region of Enrollment  
[units: participants]
 
Switzerland     25  
Body weight  
[units: kg]
Mean ± Standard Deviation
  74.2  ± 1.3  
Body Mass Index (BMI) [1]
[units: kg/m2]
Mean ± Standard Deviation
  23.5  ± 0.3  
[1] BMI is obtained by dividing the weight (kg) by the square height (m2)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Post-prandial Plasma Responses of Glucose Concentrations   [ Time Frame: 180 minutes ]

2.  Primary:   Calculation of the Area Under Curve Over Baseline for Plasma Insulin   [ Time Frame: 180 minutes from baseline ]

3.  Secondary:   Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids   [ Time Frame: 180 minutes ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Maurice Beaumont
Organization: Clinical Development Unit / Metabolic Unit
phone: +41217858054
e-mail: maurice.beaumont@rdls.nestle.com


No publications provided


Responsible Party: CDUadmin, Nestlé
ClinicalTrials.gov Identifier: NCT00712010     History of Changes
Other Study ID Numbers: 07.26.MET, Ethics: 71/08
Study First Received: July 3, 2008
Results First Received: April 9, 2013
Last Updated: July 12, 2013
Health Authority: Switzerland: Swissmedic