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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Whey protein microgels; Other: Hydrolyzed whey protein; Other: Casein native; Other: Hydrolyzed casein; Other: Total milk protein native; Other: Hydrolyzed milk protein; Other: Whey protein native

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1000
    • Nestec Clinical Development Unit / Metabolic Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Whey protein native; Whey protein native versus the 6 other arms	Other: Whey protein microgels; Whey protein microgels versus the six other arms; Other: Hydrolyzed whey protein; versus the six other arms; Other: Casein native; versus the six other arms; Other: Hydrolyzed casein; versus the six other arms; Other: Total milk protein native; versus the six other arms; Other: Hydrolyzed milk protein; versus the six other arms
EXPERIMENTAL: Whey protein microgels; Whey protein microgels versus the 6 other arms	Other: Hydrolyzed whey protein; versus the six other arms; Other: Casein native; versus the six other arms; Other: Hydrolyzed casein; versus the six other arms; Other: Total milk protein native; versus the six other arms; Other: Hydrolyzed milk protein; versus the six other arms; Other: Whey protein native; Whey protein native against the 6 other arms
EXPERIMENTAL: Hydrolyzed whey protein; Hydrolyzed whey protein versus the 6 other arms	Other: Whey protein microgels; Whey protein microgels versus the six other arms; Other: Casein native; versus the six other arms; Other: Hydrolyzed casein; versus the six other arms; Other: Total milk protein native; versus the six other arms; Other: Hydrolyzed milk protein; versus the six other arms; Other: Whey protein native; Whey protein native against the 6 other arms
EXPERIMENTAL: Casein native; Casein native versus the 6 other arms	Other: Whey protein microgels; Whey protein microgels versus the six other arms; Other: Hydrolyzed whey protein; versus the six other arms; Other: Hydrolyzed casein; versus the six other arms; Other: Total milk protein native; versus the six other arms; Other: Hydrolyzed milk protein; versus the six other arms; Other: Whey protein native; Whey protein native against the 6 other arms
EXPERIMENTAL: Hydrolyzed casein; Hydrolyzed casein versus the 6 other arms	Other: Whey protein microgels; Whey protein microgels versus the six other arms; Other: Hydrolyzed whey protein; versus the six other arms; Other: Casein native; versus the six other arms; Other: Total milk protein native; versus the six other arms; Other: Hydrolyzed milk protein; versus the six other arms; Other: Whey protein native; Whey protein native against the 6 other arms
EXPERIMENTAL: Total milk protein native; Total milk protein native versus the 6 other arms	Other: Whey protein microgels; Whey protein microgels versus the six other arms; Other: Hydrolyzed whey protein; versus the six other arms; Other: Casein native; versus the six other arms; Other: Hydrolyzed casein; versus the six other arms; Other: Hydrolyzed milk protein; versus the six other arms; Other: Whey protein native; Whey protein native against the 6 other arms
EXPERIMENTAL: Hydrolyzed milk protein; Hydrolyzed milk protein versus the 6 other arms	Other: Whey protein microgels; Whey protein microgels versus the six other arms; Other: Hydrolyzed whey protein; versus the six other arms; Other: Casein native; versus the six other arms; Other: Hydrolyzed casein; versus the six other arms; Other: Total milk protein native; versus the six other arms; Other: Whey protein native; Whey protein native against the 6 other arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids	180 minutes

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Study Director: Etienne Pouteau, Ph.D., Nestle

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): July 1, 2009
• Study Completion (ACTUAL): April 1, 2011

Study Registration Dates

• First Submitted: July 3, 2008
• First Submitted That Met QC Criteria: July 8, 2008
• First Posted (ESTIMATE): July 9, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 14, 2013
• Last Update Submitted That Met QC Criteria: July 12, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Insulin; Glucose
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: 07.26.MET; Ethics: 71/08