Healthy
Conditions
Keywords
Glucose, Insulin
Brief summary
The purpose of the clinical study is to investigate the effect of the protein quality of high-protein meal replacements on the management of post-prandial blood glucose in healthy men.
Detailed description
It was a double-blind, single center, randomized, crossover adaptive study design with 7 arms. The subjects were submitted to 7 tests of ingestion of a high-protein meal replacement (test meal) in randomized order preferably a week apart. The 7 test meals were isocaloric, isonitrogenous and differed in their protein quality.
Interventions
OTHERWhey protein native
Whey protein native against the 6 other arms
OTHERWhey protein microgels
Whey protein microgels versus the six other arms
OTHERHydrolyzed whey protein
versus the six other arms
OTHERCasein native
versus the six other arms
OTHERHydrolyzed casein
versus the six other arms
OTHERTotal milk protein native
versus the six other arms
OTHERHydrolyzed milk protein
versus the six other arms
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 20 - 50 years, male * Healthy as determined by a medical questionnaire * Normal weight: BMI 20 - 24.9 kg.m-2 * Normal fasting glycemia and insulinemia * Normal fasting lipidemia (cholesterol and triglycerides) * Normal liver function (transaminases, γ-GT) and kidney function (urea, creatinine) * Capable of fast ingestion of the meal replacement (5-10 min) * Having signed informed consent
Exclusion criteria
* Intestinal or metabolic diseases/disorders such as diabetic, renal, dyslipidemia, hepatic, hypertension, pancreatic or ulcer, including lacto-intolerance. * Hypertension \>150/95 mmHg * Have had a gastrointestinal surgery * Have a regular consumption of medication * Vegetarian, vegan, under dietary supplements * Have an alcohol intake: \> 2 units a day or smoker * Currently participating or having participated in a clinical trial during the last month * Having given blood in the last month * More than 5 x 45 min of intense exercise per week * Volunteer who cannot be expected to comply with treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-prandial Plasma Responses of Glucose Concentrations | 180 minutes | 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. |
| Calculation of the Area Under Curve Over Baseline for Plasma Insulin | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids | 180 minutes |
Countries
Switzerland
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes groups randomized to receive 7 products in a randomized series | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Washout (7 Days) | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age Continuous | 28.3 Years STANDARD_DEVIATION 1.5 |
| Age, Customized <=20 years | 0 participants |
| Age, Customized >=50 years | 0 participants |
| Age, Customized Between 20 and 50 years | 25 participants |
| Body Mass Index (BMI) | 23.5 kg/m2 STANDARD_DEVIATION 0.3 |
| Body weight | 74.2 kg STANDARD_DEVIATION 1.3 |
| Region of Enrollment Switzerland | 25 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 24 | 0 / 23 | 0 / 24 | 0 / 24 | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 23 | 0 / 24 | 0 / 24 | 0 / 23 | 0 / 23 |
Outcome results
Primary
Calculation of the Area Under Curve Over Baseline for Plasma Insulin
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Whey Protein Native | Calculation of the Area Under Curve Over Baseline for Plasma Insulin | 34,428 nmole/L*min |
| Whey Protein Microgels | Calculation of the Area Under Curve Over Baseline for Plasma Insulin | 28,756 nmole/L*min |
| Hydrolyzed Whey Protein | Calculation of the Area Under Curve Over Baseline for Plasma Insulin | 32,319 nmole/L*min |
| Casein Native | Calculation of the Area Under Curve Over Baseline for Plasma Insulin | 27,082 nmole/L*min |
| Hydrolyzed Casein | Calculation of the Area Under Curve Over Baseline for Plasma Insulin | 34,847 nmole/L*min |
| Total Milk Protein Native | Calculation of the Area Under Curve Over Baseline for Plasma Insulin | 26,476 nmole/L*min |
| Hydrolyzed Milk Protein | Calculation of the Area Under Curve Over Baseline for Plasma Insulin | 37,922 nmole/L*min |
Primary
Post-prandial Plasma Responses of Glucose Concentrations
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
Population: 23 subjects were investigated for AUC of glucose calculations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Whey Protein Native | Post-prandial Plasma Responses of Glucose Concentrations | 136.5 mmole/L*min | Standard Error 19 |
| Whey Protein Microgels | Post-prandial Plasma Responses of Glucose Concentrations | 121.2 mmole/L*min | Standard Error 13.1 |
| Hydrolyzed Whey Protein | Post-prandial Plasma Responses of Glucose Concentrations | 102.9 mmole/L*min | Standard Error 25.4 |
| Casein Native | Post-prandial Plasma Responses of Glucose Concentrations | 160.3 mmole/L*min | Standard Error 18.6 |
| Hydrolyzed Casein | Post-prandial Plasma Responses of Glucose Concentrations | 88.7 mmole/L*min | Standard Error 22.3 |
| Total Milk Protein Native | Post-prandial Plasma Responses of Glucose Concentrations | 117.7 mmole/L*min | Standard Error 15.6 |
| Hydrolyzed Milk Protein | Post-prandial Plasma Responses of Glucose Concentrations | 121.5 mmole/L*min | Standard Error 19.9 |
Secondary
Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids
Time frame: 180 minutes