Metabolic Effect of High-protein Meals in Men

Healthy Clinical Trial

— OPTI-PROT  

Official title:

Acute Metabolic Effect of the Protein Quality of a High-protein Meal Replacement in Healthy Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712010
• Other study ID #: 07.26.MET
• Secondary ID: Ethics: 71/08
• Status: Completed
• Phase: N/A
• First received: July 3, 2008
• Last updated: July 12, 2013
• Start date: July 2008
• Est. completion date: April 2011

Study information

• Verified date: July 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2011
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Whey protein native
Whey protein native against the 6 other arms
• Whey protein microgels
Whey protein microgels versus the six other arms
• Hydrolyzed whey protein
versus the six other arms
• Casein native
versus the six other arms
• Hydrolyzed casein
versus the six other arms
• Total milk protein native
versus the six other arms
• Hydrolyzed milk protein
versus the six other arms

Locations

Country	Name	City	State
Switzerland	Nestec Clinical Development Unit / Metabolic Unit	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	180 minutes	No
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.	180 minutes from baseline	No
Secondary	Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids		180 minutes	No