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Trial Outcomes & Findings for Metabolic Effect of High-protein Meals in Men (NCT NCT00712010)

NCT ID: NCT00712010

Last Updated: 2013-08-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

180 minutes

Results posted on

2013-08-14

Participant Flow

Participants were recruited among the Nestlé Research Center staff from June 2008 to May 2009

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.

Participant milestones

Participant milestones
Measure
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.
1st Protein Testing (1 Day)
STARTED
24
1st Protein Testing (1 Day)
COMPLETED
24
1st Protein Testing (1 Day)
NOT COMPLETED
0
Washout (7 Days)
STARTED
23
Washout (7 Days)
COMPLETED
23
Washout (7 Days)
NOT COMPLETED
0
2nd Protein Testing (1 Day)
STARTED
24
2nd Protein Testing (1 Day)
COMPLETED
24
2nd Protein Testing (1 Day)
NOT COMPLETED
0
3rd Protein Testing (1 Day)
STARTED
24
3rd Protein Testing (1 Day)
COMPLETED
24
3rd Protein Testing (1 Day)
NOT COMPLETED
0
4th Protein Testing (1 Day)
STARTED
24
4th Protein Testing (1 Day)
COMPLETED
24
4th Protein Testing (1 Day)
NOT COMPLETED
0
5th Protein Testing (1 Day)
STARTED
23
5th Protein Testing (1 Day)
COMPLETED
23
5th Protein Testing (1 Day)
NOT COMPLETED
0
6th Protein Testing (1 Day)
STARTED
23
6th Protein Testing (1 Day)
COMPLETED
23
6th Protein Testing (1 Day)
NOT COMPLETED
0
7th and Last Protein Testing (1 Day)
STARTED
23
7th and Last Protein Testing (1 Day)
COMPLETED
23
7th and Last Protein Testing (1 Day)
NOT COMPLETED
0

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
Washout (7 Days)
Withdrawal by Subject
1

Baseline Characteristics

Metabolic Effect of High-protein Meals in Men

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Entire Study Population
n=25 Participants
Includes groups randomized to receive 7 products in a randomized series
Age Continuous
28.3 Years
STANDARD_DEVIATION 1.5 • n=5 Participants
Age, Customized
<=20 years
0 participants
n=5 Participants
Age, Customized
Between 20 and 50 years
25 participants
n=5 Participants
Age, Customized
>=50 years
0 participants
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
25 Participants
n=5 Participants
Region of Enrollment
Switzerland
25 participants
n=5 Participants
Body weight
74.2 kg
STANDARD_DEVIATION 1.3 • n=5 Participants
Body Mass Index (BMI)
23.5 kg/m2
STANDARD_DEVIATION 0.3 • n=5 Participants

PRIMARY outcome

Timeframe: 180 minutes

Population: 23 subjects were investigated for AUC of glucose calculations

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.

Outcome measures

Outcome measures
Measure
Whey Protein Native
n=24 Participants
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Whey Protein Microgels
n=24 Participants
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Hydrolyzed Whey Protein
n=23 Participants
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Casein Native
n=24 Participants
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Hydrolyzed Casein
n=24 Participants
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Total Milk Protein Native
n=23 Participants
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Hydrolyzed Milk Protein
n=23 Participants
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Post-prandial Plasma Responses of Glucose Concentrations
136.5 mmole/L*min
Standard Error 19
121.2 mmole/L*min
Standard Error 13.1
102.9 mmole/L*min
Standard Error 25.4
160.3 mmole/L*min
Standard Error 18.6
88.7 mmole/L*min
Standard Error 22.3
117.7 mmole/L*min
Standard Error 15.6
121.5 mmole/L*min
Standard Error 19.9

PRIMARY outcome

Timeframe: 180 minutes from baseline

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.

Outcome measures

Outcome measures
Measure
Whey Protein Native
n=23 Participants
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Whey Protein Microgels
n=23 Participants
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Hydrolyzed Whey Protein
n=23 Participants
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Casein Native
n=23 Participants
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Hydrolyzed Casein
n=23 Participants
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Total Milk Protein Native
n=23 Participants
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Hydrolyzed Milk Protein
n=23 Participants
High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
Calculation of the Area Under Curve Over Baseline for Plasma Insulin
34,428 nmole/L*min
Standard Error 2,678
28,756 nmole/L*min
Standard Error 2,383
32,319 nmole/L*min
Standard Error 2,760
27,082 nmole/L*min
Standard Error 2,283
34,847 nmole/L*min
Standard Error 2,267
26,476 nmole/L*min
Standard Error 1,699
37,922 nmole/L*min
Standard Error 3,970

SECONDARY outcome

Timeframe: 180 minutes

Outcome measures

Outcome data not reported

Adverse Events

Whey Protein Native

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Whey Protein Microgels

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Hydrolyzed Whey Protein

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Casein Native

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Hydrolyzed Casein

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Total Milk Protein Native

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Hydrolyzed Milk Protein

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Maurice Beaumont

Clinical Development Unit / Metabolic Unit

Phone: +41217858054

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place