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Metabolic Effect of High-protein Meals in Men

NCT ID: NCT00712010

Last Updated: 2013-08-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-04-30

Brief Summary

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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

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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.

Conditions

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Healthy

Keywords

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Glucose Insulin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Whey protein native

Whey protein native versus the 6 other arms

Group Type EXPERIMENTAL

Whey protein microgels

Intervention Type OTHER

Whey protein microgels versus the six other arms

Hydrolyzed whey protein

Intervention Type OTHER

versus the six other arms

Casein native

Intervention Type OTHER

versus the six other arms

Hydrolyzed casein

Intervention Type OTHER

versus the six other arms

Total milk protein native

Intervention Type OTHER

versus the six other arms

Hydrolyzed milk protein

Intervention Type OTHER

versus the six other arms

Whey protein microgels

Whey protein microgels versus the 6 other arms

Group Type EXPERIMENTAL

Whey protein native

Intervention Type OTHER

Whey protein native against the 6 other arms

Hydrolyzed whey protein

Intervention Type OTHER

versus the six other arms

Casein native

Intervention Type OTHER

versus the six other arms

Hydrolyzed casein

Intervention Type OTHER

versus the six other arms

Total milk protein native

Intervention Type OTHER

versus the six other arms

Hydrolyzed milk protein

Intervention Type OTHER

versus the six other arms

Hydrolyzed whey protein

Hydrolyzed whey protein versus the 6 other arms

Group Type EXPERIMENTAL

Whey protein native

Intervention Type OTHER

Whey protein native against the 6 other arms

Whey protein microgels

Intervention Type OTHER

Whey protein microgels versus the six other arms

Casein native

Intervention Type OTHER

versus the six other arms

Hydrolyzed casein

Intervention Type OTHER

versus the six other arms

Total milk protein native

Intervention Type OTHER

versus the six other arms

Hydrolyzed milk protein

Intervention Type OTHER

versus the six other arms

Casein native

Casein native versus the 6 other arms

Group Type EXPERIMENTAL

Whey protein native

Intervention Type OTHER

Whey protein native against the 6 other arms

Whey protein microgels

Intervention Type OTHER

Whey protein microgels versus the six other arms

Hydrolyzed whey protein

Intervention Type OTHER

versus the six other arms

Hydrolyzed casein

Intervention Type OTHER

versus the six other arms

Total milk protein native

Intervention Type OTHER

versus the six other arms

Hydrolyzed milk protein

Intervention Type OTHER

versus the six other arms

Hydrolyzed casein

Hydrolyzed casein versus the 6 other arms

Group Type EXPERIMENTAL

Whey protein native

Intervention Type OTHER

Whey protein native against the 6 other arms

Whey protein microgels

Intervention Type OTHER

Whey protein microgels versus the six other arms

Hydrolyzed whey protein

Intervention Type OTHER

versus the six other arms

Casein native

Intervention Type OTHER

versus the six other arms

Total milk protein native

Intervention Type OTHER

versus the six other arms

Hydrolyzed milk protein

Intervention Type OTHER

versus the six other arms

Total milk protein native

Total milk protein native versus the 6 other arms

Group Type EXPERIMENTAL

Whey protein native

Intervention Type OTHER

Whey protein native against the 6 other arms

Whey protein microgels

Intervention Type OTHER

Whey protein microgels versus the six other arms

Hydrolyzed whey protein

Intervention Type OTHER

versus the six other arms

Casein native

Intervention Type OTHER

versus the six other arms

Hydrolyzed casein

Intervention Type OTHER

versus the six other arms

Hydrolyzed milk protein

Intervention Type OTHER

versus the six other arms

Hydrolyzed milk protein

Hydrolyzed milk protein versus the 6 other arms

Group Type EXPERIMENTAL

Whey protein native

Intervention Type OTHER

Whey protein native against the 6 other arms

Whey protein microgels

Intervention Type OTHER

Whey protein microgels versus the six other arms

Hydrolyzed whey protein

Intervention Type OTHER

versus the six other arms

Casein native

Intervention Type OTHER

versus the six other arms

Hydrolyzed casein

Intervention Type OTHER

versus the six other arms

Total milk protein native

Intervention Type OTHER

versus the six other arms

Interventions

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Whey protein native

Whey protein native against the 6 other arms

Intervention Type OTHER

Whey protein microgels

Whey protein microgels versus the six other arms

Intervention Type OTHER

Hydrolyzed whey protein

versus the six other arms

Intervention Type OTHER

Casein native

versus the six other arms

Intervention Type OTHER

Hydrolyzed casein

versus the six other arms

Intervention Type OTHER

Total milk protein native

versus the six other arms

Intervention Type OTHER

Hydrolyzed milk protein

versus the six other arms

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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CDUadmin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Etienne Pouteau, Ph.D.

Role: STUDY_DIRECTOR

Société des Produits Nestlé (SPN)

Locations

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Nestec Clinical Development Unit / Metabolic Unit

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Ethics: 71/08

Identifier Type: -

Identifier Source: secondary_id

07.26.MET

Identifier Type: -

Identifier Source: org_study_id