|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00712010 |
|
Date of registration:
|
03/07/2008 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Metabolic Effect of High-protein Meals in Men
OPTI-PROT |
|
Scientific title:
|
Acute Metabolic Effect of the Protein Quality of a High-protein Meal Replacement in Healthy Men |
|
Date of first enrolment:
|
July 2008 |
|
Target sample size:
|
25 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00712010 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Switzerland
| | | | | | | |
|
Contacts
|
|
Name:
|
Etienne Pouteau, Ph.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Nestlé |
| | |
|
Key inclusion & exclusion criteria
|
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, ?-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
Age minimum:
20 Years
Age maximum:
50 Years
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Healthy
|
|
Intervention(s)
|
|
Other: Total milk protein native
|
|
Other: Whey protein microgels
|
|
Other: Casein native
|
|
Other: Hydrolyzed casein
|
|
Other: Hydrolyzed milk protein
|
|
Other: Hydrolyzed whey protein
|
|
Other: Whey protein native
|
|
Primary Outcome(s)
|
|
Calculation of the Area Under Curve Over Baseline for Plasma Insulin
[Time Frame: 180 minutes from baseline]
|
|
Post-prandial Plasma Responses of Glucose Concentrations
[Time Frame: 180 minutes]
|
|
Secondary Outcome(s)
|
|
Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids
[Time Frame: 180 minutes]
|
|
Secondary ID(s)
|
|
07.26.MET
|
|
Ethics: 71/08
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|