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

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ClinicalTrials.gov Identifier: NCT00712010
Recruitment Status : Completed
First Posted : July 9, 2008
Results First Posted : August 14, 2013
Last Update Posted : August 14, 2013
Sponsor:
Information provided by (Responsible Party):
CDUadmin, Nestlé

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, 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
Enrollment 25
Recruitment Details Participants were recruited among the Nestlé Research Center staff from June 2008 to May 2009
Pre-assignment Details 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.
Arm/Group Title 7 Proteins Were Tested Randomly
Hide Arm/Group Description

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.
Period Title: 1st Protein Testing (1 Day)
Started 24 [1]
Completed 24
Not Completed 0
[1]
1 subject withdrew his consent form before to starting the 1st intervention
Period Title: Washout (7 Days)
Started 24
Completed 24
Not Completed 0
Period Title: 2nd Protein Testing (1 Day)
Started 24
Completed 24
Not Completed 0
Period Title: Washout (7 Days)
Started 24
Completed 24
Not Completed 0
Period Title: 3rd Protein Testing (1 Day)
Started 24
Completed 24
Not Completed 0
Period Title: Washout (7 Days)
Started 24
Completed 24
Not Completed 0
Period Title: 4th Protein Testing (1 Day)
Started 24
Completed 24
Not Completed 0
Period Title: Washout (7 Days)
Started 24
Completed 23
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Period Title: 5th Protein Testing (1 Day)
Started 23
Completed 23
Not Completed 0
Period Title: Washout (7 Days)
Started 23
Completed 23
Not Completed 0
Period Title: 6th Protein Testing (1 Day)
Started 23
Completed 23
Not Completed 0
Period Title: Washout (7 Days)
Started 23
Completed 23
Not Completed 0
Period Title: 7th and Last Protein Testing (1 Day)
Started 23
Completed 23
Not Completed 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes groups randomized to receive 7 products in a randomized series
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
Participants were recruited amoung the Nestlé Research Center staff.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
28.3  (1.5)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants
<=20 years 0
Between 20 and 50 years 25
>=50 years 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
0
   0.0%
Male
25
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Switzerland Number Analyzed 25 participants
25
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 25 participants
74.2  (1.3)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 25 participants
23.5  (0.3)
[1]
Measure Description: BMI is obtained by dividing the weight (kg) by the square height (m2)
1.Primary Outcome
Title Post-prandial Plasma Responses of Glucose Concentrations
Hide Description The concentrations of glucose were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.
Time Frame 180 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
23 subjects were investigated for AUC of glucose calculations
Arm/Group Title Whey Protein Native Whey Protein Microgels Hydrolyzed Whey Protein Casein Native Hydrolyzed Casein Total Milk Protein Native Hydrolyzed Milk Protein
Hide Arm/Group Description:
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Overall Number of Participants Analyzed 24 24 23 24 24 23 23
Mean (Standard Error)
Unit of Measure: mmole/L*min
136.5  (19) 121.2  (13.1) 102.9  (25.4) 160.3  (18.6) 88.7  (22.3) 117.7  (15.6) 121.5  (19.9)
2.Primary Outcome
Title Calculation of the Area Under Curve Over Baseline for Plasma Insulin
Hide Description The concentrations of insulin were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.
Time Frame 180 minutes from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whey Protein Native Whey Protein Microgels Hydrolyzed Whey Protein Casein Native Hydrolyzed Casein Total Milk Protein Native Hydrolyzed Milk Protein
Hide Arm/Group Description:
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Overall Number of Participants Analyzed 23 23 23 23 23 23 23
Mean (Standard Error)
Unit of Measure: nmole/L*min
34,428  (2,678) 28,756  (2,383) 32,319  (2,760) 27,082  (2,283) 34,847  (2,267) 26,476  (1,699) 37,922  (3,970)
3.Secondary Outcome
Title Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids
Hide Description [Not Specified]
Time Frame 180 minutes
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Whey Protein Native Whey Protein Microgels Hydrolyzed Whey Protein Casein Native Hydrolyzed Casein Total Milk Protein Native Hydrolyzed Milk Protein
Hide Arm/Group Description High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes. High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
All-Cause Mortality
Whey Protein Native Whey Protein Microgels Hydrolyzed Whey Protein Casein Native Hydrolyzed Casein Total Milk Protein Native Hydrolyzed Milk Protein
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Whey Protein Native Whey Protein Microgels Hydrolyzed Whey Protein Casein Native Hydrolyzed Casein Total Milk Protein Native Hydrolyzed Milk Protein
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%)   0/23 (0.00%)   0/24 (0.00%)   0/24 (0.00%)   0/23 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Whey Protein Native Whey Protein Microgels Hydrolyzed Whey Protein Casein Native Hydrolyzed Casein Total Milk Protein Native Hydrolyzed Milk Protein
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%)   0/23 (0.00%)   0/24 (0.00%)   0/24 (0.00%)   0/23 (0.00%)   0/23 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Maurice Beaumont
Organization: Clinical Development Unit / Metabolic Unit
Phone: +41217858054
EMail: maurice.beaumont@rdls.nestle.com
Layout table for additonal information
Responsible Party: CDUadmin, Nestlé
ClinicalTrials.gov Identifier: NCT00712010     History of Changes
Other Study ID Numbers: 07.26.MET
Ethics: 71/08
First Submitted: July 3, 2008
First Posted: July 9, 2008
Results First Submitted: April 9, 2013
Results First Posted: August 14, 2013
Last Update Posted: August 14, 2013